Surgical instruments and procedures for stabilizing a localized portion of a beating heart

ABSTRACT

In accordance with the present invention, there is disclosed surgical methods and apparatus for accessing and stabilizing the heart. The methods and apparatus facilitate access to an anastomosis site, allows various instruments or devices to be maneuvered and secured in place, and provide stabilization of the heart. The apparatus may involve a tissue stabilizer, and in particular a tissue stabilizer for use in immobilizing or stabilizing a portion of the beating heart using a compressive force delivered to the heart via the tissue stabilizer. The stabilizer may include a stabilizer base and a shaft. The shaft may be secured within an appropriate instrument mount preferably fixed to a retractor or other stable platform as disclosed herein. The stabilizers of the present invention provide improved access to a surgical site at a target vessel on the surface of the heart and may include features which facilitate optimal presentation of the target vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of co-pending U.S.application Ser. No. 08/931,158 filed Sep. 16, 1997, which is acontinuation-in-part of U.S. application Ser. No. 08/789,751 filed Jan.27, 1997, which is a continuation-in-part of U.S. application Ser. No.08/603,758 filed Feb. 20, 1996.

FIELD OF THE INVENTION

[0002] The present invention relates generally to surgical instruments,and more particularly to surgical retractor, instrument mount, andtissue stabilizer devices for use during coronary artery bypass graftsurgery.

BACKGROUND OF THE INVENTION

[0003] Diseases of the cardiovascular system affect millions of peopleeach year and are a leading cause of death throughout the world. Thecost to society from such diseases is enormous both in terms of thenumber of lives lost as well as in terms of the costs associated withtreating patients through traditional surgical techniques. Aparticularly prevalent form of cardiovascular disease is a reduction inthe blood supply leading to the heart caused by atherosclerosis or othercondition that creates a restriction in blood flow at a critical pointin the cardiovascular system that supplies blood to the heart.

[0004] Treatment of such a blockage or restriction in the blood flowleading to the heart is, in many cases, treated by a surgical procedureknown as a coronary artery bypass graft (CABG) procedure, more commonlyknown as a “heart bypass” operation. In the CABG procedure, the surgeon“bypasses” the obstruction to restore normal blood flow to the hearteither by attaching an available source vessel to the obstructed targetcoronary artery or by removing a portion of a vein or artery fromanother part of the body, to use as a graft, and installing the graftbetween a point on a source vessel and a point on a target artery.

[0005] To restore the flow of blood to the heart, the CABG procedurerequires that a fluid connection be established between two vessels.This procedure is known as an “anastomosis.” Typically, a source vessel,such as a source artery with an unobstructed blood flow, i.e., the leftinternal mammary artery (LIMA), or a bypass-graft having one end sewn toan unobstructed blood source such as the aorta, is sewn to a targetoccluded coronary artery, such as the left anterior descending (LAD)artery or other vessel, that provides blood flow to the muscles of theheart.

[0006] Although the CABG procedure has become relatively common, theprocedure itself is lengthy and traumatic and can damage the heart, thecardiovascular system, the central nervous system, and the blood supplyitself. In a conventional CABG procedure, the surgeon makes an incisiondown the center of the chest, cuts through the sternum, performs severalother procedures necessary to attach the patient to a heart-lung bypassmachine, cuts off the blood flow to the heart, and then stops the heartfrom beating in order to complete the bypass. The most lengthy andtraumatic surgical procedures are necessary, in part, to connect thepatient to a cardiopulmonary bypass (CPB) machine to continue thecirculation of oxygenated blood to the rest of the body while the bypassis completed.

[0007] In recent years, a growing number of surgeons have begunperforming CABG procedures using surgical techniques especiallydeveloped so that the CABG procedure could be performed while the heartis still beating. In such procedures, there is no need for any form ofcardiopulmonary bypass, no need to perform the extensive surgicalprocedures necessary to connect the patient to a cardiopulmonary bypassmachine, and no need to stop the heart. As a result, these beating heartprocedures are much less invasive and the entire procedure can typicallybe achieved through a small number, typically one or two, comparativelysmall incisions in the chest.

[0008] Despite the advantages, the beating-heart CABG procedure is notuniversally practiced, at least in part, because of the difficulty inperforming the necessary surgical procedures using conventional surgicalinstruments. For example, it has been difficult for the surgeon toaccess the required areas of the heart requiring revascularization. Inaddition, the various surgical steps that are required to be performedon the heart itself are more difficult to perform because the heartmuscle continues to move and contract to pump blood throughout theduration of the procedure.

[0009] The specific portion of the surgical procedure that creates theanastomosis in the beating-heart CABG procedure is particularlydifficult. Completion of the anastomosis requires placing a series ofsutures through extremely small vessels on the surface of the heartwhile the heart muscle continues to beat. Moreover, the sutures must becarefully placed to ensure that the source vessel or graft is firmlyattached and will not leak when blood flow through the vessel isestablished. In cases where the target coronary artery is temporarilyobstructed, for example, to improve the surgeon's visibility and avoidexcessive blood loss, it is also important that the anastomosisprocedure be performed rapidly to avoid ischemic damage to the heart.

[0010] Further adding to the difficulty of the procedure is the factthat the working space and visual access are often quite limited. Thesurgeon may be working through a small incision in the chest, forexample, or may be viewing the procedure on a video monitor if the siteof the surgery is viewed via surgical scope. The vessel, andparticularly the arteriotomy to which a source vessel is to beanastomosed, may also be very difficult for the surgeon to see as it maybe obscured more or less by layers of fat or other tissue.

[0011] The beating-heart CABG procedure could be greatly improved if theheart could be accessed and stabilized during the procedure such thatthe motion of the heart, particularly at the site of the anastomosis, isminimized even though the heart continues to beat and supply blood tothe body. The beating-heart CABG procedure could be further improved ifthe target vessel, and specifically the arteriotomy was presented to thesurgeon in a way that allows sutures to be easily placed.

[0012] In view of the foregoing, it would be desirable to have improveddevices for accessing and effectively stabilizing the beating heart atthe site of the anastomosis. It would be desirable to have alow-profile, atraumatic stabilizing device that stabilizes the beatingheart at the site of the anastomosis and provides a favorablepresentation of the target vessel and the arteriotomy. It would befurther desirable to provide a mount for the stabilizing device, orother instruments, that allows the stabilizing device to be easilymaneuvered to the desired position and orientation, fixedly secureduntil the procedure is completed, and then easily removed from the siteof the anastomosis. It would also be desirable to have a retractorsystem for use in conjunction with the stabilizer that providesunobstructed and organized access to the areas of the heart requiringrevascularization.

SUMMARY OF THE INVENTION

[0013] The present invention will be described for use in stabilizingthe beating heart during CABG surgery, but the invention is not limitedthereto, and is contemplated to be useful for other surgical proceduresrequiring body tissue or organs to be immobilized or stabilized.

[0014] The present invention involves various aspects of tissuestabilizer devices, and in particular a tissue stabilizer for use inimmobilizing or stabilizing a portion of the beating heart using acompressive force delivered to the heart via the tissue stabilizer. Thestabilizer may include a stabilizer base and a shaft. The shaft may besecured within an appropriate instrument mount preferably fixed to aretractor or other stable platform. The stabilizers of the presentinvention provide improved access to a surgical site at a target vesselon the surface of the heart and may include features which facilitateoptimal presentation of the target vessel.

[0015] One aspect of the present invention involves an apparatus forstabilizing a localized portion of a beating heart comprising a basemember having a wire frame coupled to the base member. The base memberis preferably substantially rigid having at least one contact areaadapted to frictionally engage the surface of the beating heart adjacenta first side of a target vessel. The wire frame may have a frame portionadapted to engage the beating heart adjacent a second side of saidtarget vessel opposite to the first side and at least one leg portionconnecting the frame to the base member. Preferably, the leg portion issubstantially perpendicular to the frame portion. In a preferredembodiment, the frame portion is parallel to a central axis of the basemember.

[0016] The leg portion is preferably flexible relative to the basemember and may have a vertically relieved portion in the area where itwould cross over the vessel between the contact area and the frameportion. In a preferred embodiment, the leg portion is formed from aunitary length of wire material. The wire material may be selected fromstainless steel or titanium and may have a round or squarecross-section. In one embodiment, the frame portion is vertically offsetfrom the contact area, preferably by a distance of about 0.05 inches toabout 0.2 inches. The contact area may be planar or curved to conform tothe surface of the heart. The base member may have more than one contactarea and most preferably two contact areas separated by an open space.

[0017] A shaft may be connected to the base member. Preferably, the basemember of the stabilizer is operably connected to the distal end of theshaft. The shaft may be any configuration suitable for delivering therequired compressive forces to the base member, but is preferably asubstantially rigid shaft. The shaft may be straight, or morepreferably, curved.

[0018] Preferably, the wire frame is moveable relative to the basemember. In one embodiment, the base member includes a channel forslidably receiving at least a portion of the leg portion. The legportion may have a plurality of detented positions with the channel. Thedetented positions may result from the channel having a plurality ofteeth and the leg portion having a plurality of mating teeth adapted toengage the channel teeth. The position of the wire frame relative to thebase member may be manually positioned between the detented positions.

[0019] The wire frame may be also be moveable using a rack and pinionarrangement, a threaded shaft and collar arrangement, or other likedriving mechanism. In one embodiment, the base member includes a piniongear having a plurality of gear teeth and the leg portion includes arack having a plurality of mating teeth adapted to engage the gear teethon the pinion. The wire frame can be moved in and out relative to thebase member by rotating the gear. In another embodiment, the base memberincludes a threaded shaft rotatably coupled to the base member and theleg portion includes a collar having a threaded interior adapted toreceive the threaded shaft. In that case, the wire frame can be moved inand out relative to the base member by rotating the threaded shaftcausing the collar to move along the shaft.

[0020] The frame portion may have a first end and a second end eachhaving a leg portion extending therefrom. Each leg portion may beremovably attached to said base member. The base member may include afirst and second channel for slidably receiving each leg portion. Thewire frame may preferably be attached to from either side of the basemember. When the wire frame is attached to the base member using two legportions, the wire frame is preferably detachable from said base memberto facilitate its removal from a completed anastomosis on the targetvessel.

[0021] In another aspect of the present invention, an apparatus forstabilizing a localized portion of beating heart may include a basemember having a post which is offset from the center of the base member.In a preferred embodiment, a substantially rigid base member is formedfrom a unitary piece of sheet material having a first side and secondside. The base member may have a first section adapted to contact thesurface of the beating heart and a second section at a fixed anglerelative to the first section. The first section defines a first contactsurface, a second contact surface and an open space between said firstand second contact surface. A first end of the post is connected to thesecond section at a location which is offset from the open space betweenthe first and second contact surfaces. A second end of the postterminates with at least a portion of a ball extending therefrom.

[0022] A shaft may be connected to the second end of the post.Preferably, the distal end of the shaft has a socket operably engagedwith the portion of the ball at the end of the post. Preferably, theshaft is curved and substantially rigid.

[0023] In one embodiment, the angle between the first section and thesecond section may be from about 75 degrees to about 105 degrees, mostpreferably about 90 degrees, and the post is attached to and extendsfrom the first side of the sheet material. In another embodiment, theangle is more than about 120 degrees and the post is attached to andextends from the second side of the sheet material.

[0024] In another aspect of the present invention, the apparatus forstabilizing a localized portion of a beating heart includes asubstantially rigid base member having at least one surface adapted tocontact the surface of the heart and a post having a first end moveablycoupled to the base member and a second end having a ball or aball-shaped member extending therefrom. A shaft, preferably a rigidshaft, may be provided with a distal end having a socket operablyengaged with the ball.

[0025] In one embodiment, the base member has a first section having atleast one surface for contacting the surface of a heart and a secondsection adjacent the first section. Preferably, the moveable post isattached to the second section. The second section may be at an anglerelative to the first section. The second section may have a slotadapted to receive the first end of the post which is moveable withinthe slot from a first position to a second position.

[0026] In another embodiment, at least a portion of the base member hasa curved outer profile and the post is mounted to a top member having aninterior profile adapted to engage and concentrically rotate about thecurved outer profile. The base member may have at least one elongateslot. The top member may have one or more extending features or tabsengaged within the slot or slots. Preferably, the interior profile ofthe top member is close fitting with the curved outer profile of thebase member. Most preferably, the top member encircles more than 180degrees of the base member thereby capturing the base member within thetop member.

[0027] In another aspect of the present invention, the apparatus forstabilizing a localized portion of a beating heart includes a basemember having a post attached to a pivotable link member. Pivoting thelink to one or more different positions correspondingly moves the postto one or more different positions, including positions offset from thecenter area of the base member in a right or left direction. In apreferred embodiment, the base member has at least one surface adaptedto contact the surface of the heart. The link member may be pivotablycoupled to the base member at a predetermined pivot point and has afirst link end spaced a distance away from the pivot point. A first endof the post is attached to the first link end and a second post endincludes at least a portion of a ball extending therefrom. A shaft,preferably a rigid shaft, may be operably coupled to the ball.Preferably, the shaft has a socket an a distal end which engages theball.

[0028] The link member may also have a second link end opposite thefirst link end. The second link end may be releasably locked to saidbase member to substantially prevent relative movement of the linkmember relative to the base member. The second link end is releasablesuch that the link member can be pivoted about the pivot point to allowthe post to be moved from one position to another. Preferably, the linkmember pivots about a pivot pin extending from the base member. The basemember may have a first contact surface, a second contact surface and anopen space therebetween. The link member preferably provides a firstposition where the post is laterally offset from the open space in afirst direction and second position where the post is laterally offsetfrom the open space in a second direction. Thus, the post can beadvantageously moved from a lefthand position to a right-hand position.

[0029] These and other features of the present invention will becomemore fully apparent from the following description and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0030]FIG. 1 is a perspective view illustrating a cardiac surgery systemaccording to the principles of the present invention.

[0031]FIG. 2 is a perspective view illustrating a retractor assemblyaccording to the principles of the present invention.

[0032]FIG. 3 is a perspective view illustrating a preferred retractordrive assembly.

[0033]FIG. 4 is a perspective view illustrating an exemplar barassembly.

[0034]FIG. 5 is a perspective view illustrating a moveable housingassociated with the retractor drive.

[0035]FIG. 6 is a perspective view illustrating a retractor drive handleassembly.

[0036]FIG. 7 is a top plan view illustrating a preferred platform bladeand retractor drive assembly in an unengaged position.

[0037]FIG. 8 is a top view in partial cross-section illustrating theplatform blade and retractor drive assembly in an engaged position.

[0038]FIG. 9 is a cross-sectional view taken along line 9-9 shown inFIG. 8.

[0039]FIG. 10 is a partial top view illustrating a preferred suture stayarrangement associated with a platform blade.

[0040]FIGS. 11A, 11B, and 11C illustrate a preferred platform bladelatch. FIGS. 11A and 11B are top and front plan view, respectively. FIG.11C is a cross-sectional view taken along line 11C-11C as shown in FIG.11B.

[0041]FIG. 12 is a perspective view showing a preferred suture lock.

[0042]FIG. 13 is a perspective view illustrating an instrument mountassembly according to the principles of the present invention.

[0043]FIG. 14 is an exploded assembly illustration of the instrumentmount assembly of FIG. 13.

[0044]FIGS. 15A and 15B are perspective views illustrating the assemblyof the mount cam to the mount base.

[0045]FIGS. 16A and 16B are top and front plan views, respectively,illustrating a preferred mount cam.

[0046]FIG. 17 is a front plan view illustrating a preferred mount hinge.

[0047]FIG. 18 is an exploded view illustrating the assembly of the mountbody to the mount base.

[0048]FIG. 19 is an exploded view illustrating the assembly of theinstrument clamp to the mount body.

[0049]FIG. 20 is a cross-sectional view taken through a horizontal planeof the instrument shaft grip of FIG. 19.

[0050]FIG. 21 is a front plan view showing an assembled instrument mountoperably positioned on a platform blade according to the principles ofthe present invention.

[0051]FIGS. 22A and 22B are front and top plan views, respectively, ofan alternate instrument mount assembly according to the principles ofthe present invention.

[0052]FIG. 23 is a cross-sectional view taken along line 23-23 as shownin FIG. 21.

[0053]FIG. 24 is an offset cross-sectional view taken along line 24-24as shown in FIG. 22 illustrating the mount assembly of FIGS. 21 and 22in the closed position.

[0054]FIG. 25 is an offset cross-sectional view illustrating the mountassembly of FIGS. 21 and 22 in the open position.

[0055]FIG. 26 is an exploded assembly view showing selected componentsof a preferred closing mechanism.

[0056]FIG. 27 is a perspective view illustrating a preferred instrumentmount cam post.

[0057]FIG. 28 is a perspective view illustrating a preferred instrumentmount release button.

[0058]FIG. 29 is a perspective view illustrating a preferred instrumentmount follower post.

[0059]FIG. 30 is a perspective view of a preferred instrument mountshaft clamp.

[0060]FIG. 31 is a perspective view of a preferred instrument mountconical clutch.

[0061]FIG. 32 is a perspective view of a threaded collar associated withthe instrument mount shaft clamp.

[0062]FIGS. 33 and 34 are exploded perspective and cross-sectional viewsrespectively of a handle mechanism of a preferred tissue stabilizer.

[0063]FIG. 35 is an exploded perspective view of a contact member of thestabilizer shown in FIGS. 33 and 34.

[0064]FIG. 36 is a rear plan view of the contact member of FIGS. 33, 34and 35.

[0065]FIG. 37 is a cross-sectional view of the contact member of FIG. 36taken along line 37-37.

[0066]FIG. 38 is a perspective view illustrating a stabilizer baseembodiment having an offset shaft connection.

[0067]FIG. 39 is a perspective view illustrating an alternative offsetstabilizer base in use over a target vessel.

[0068]FIGS. 40A and 40B are respectively front and side plan views ofthe offset stabilizer base embodiment of FIG. 39.

[0069]FIG. 41 is a perspective view of a tissue stabilizer having amoveable ball/post.

[0070]FIG. 42 is a perspective view illustrating another tissuestabilizer embodiment having a moveable ball/post.

[0071]FIG. 43 is a partial cross-section taken through the ball/post ofFIG. 42 showing a spring biased ball/post.

[0072]FIG. 44 is a partial cross-section showing the ball/post of FIG.43 utilizing a locking clip to secure the ball/post.

[0073]FIG. 45 is a perspective view of the locking clip of FIG. 44.

[0074]FIG. 46 is a perspective view illustrating another moveableball/post stabilizer embodiment.

[0075]FIG. 47 is a front perspective exploded view of a stabilizer baseassembly having an adjustable ball/post position.

[0076]FIG. 48 is a rear perspective view of the stabilizer base of FIG.47.

[0077]FIGS. 49A and 49B are front and rear perspective views of thestabilizer base assembly of FIG. 47.

[0078]FIG. 50 is a partial cross-sectional view through a portion of therear guide slot of the stabilizer base of FIG. 47.

[0079]FIG. 51A is a perspective view of a stabilizer base embodimenthaving a single contact member and bail construction.

[0080]FIG. 51B is an end plan view of the stabilizer embodiment of FIG.51A.

[0081]FIG. 52A and 52B are perspective views illustrating anotherstabilizer base embodiment having a single contact member and bailconstruction.

[0082]FIGS. 53 and 54 are perspective views illustrating stabilizer baseembodiments having a single contact member and a bail having amechanical drive.

[0083]FIG. 55 is a perspective view of a preferred cardiac surgerysystem during operation according to the principles of the presentinvention.

DETAILED DESCRIPTION

[0084] The present invention involves surgical instruments stabilizingthe heart and methods for their use. The present invention may alsoinclude a mount that allows various instruments to be easily positionedwithin the surgical working space, locked or secured into a desiredposition for the duration of a particular surgical procedure, and theneasily and safely removed from the working space. The present inventionmay also involve a retractor system or assembly for accessing the heart.

[0085] Although the instruments and methods of the present invention mayhave application in both conventional stopped-heart and beating heartprocedures, they are preferably used to access and stabilize the beatingheart during a minimally invasive coronary artery bypass graft (CABG)operation which has been specially developed to facilitate completion ofan anastomosis, typically between a target artery and a bypass graft orsource artery, without requiring cardiac arrest such as cardioplegia orfibrillation and without cardiopulmonary bypass (CPB). Further, althoughthe instruments for accessing and stabilizing the beating heart can beapplied in a number of different surgical contexts involving variousincisions and surgical approaches to the heart as are known in the art,the instruments and devices described herein are most advantageouslyemployed in a CABG procedure wherein the heart is accessed through onlyone or two minimally invasive incisions in the chest.

[0086] Although the particular source vessel and target artery of theanastomosis are determined clinically, a common minimally invasivebypass procedure on the beating heart includes an anastomosis whichforms a connection between the left internal mammary artery (LIMA) asthe source artery, and the left anterior descending artery (LAD) as thetarget artery. To complete the anastomosis, the surgeon must dissect aportion of the LIMA by separating it from the internal chest cavity.Once dissection of the LIMA is achieved, the surgeon may attach thedissected LIMA to the target coronary artery, i.e., the LAD by way ofcreating an anastomosis.

[0087] In this example, the present invention may involve a number ofdiscreet components that facilitate access to the anastomosis site,allow various instruments or devices to be maneuvered and secured inplace, and provide stabilization of the heart. The various stabilizerembodiments of the present invention may be used to stabilize thebeating heart during at least the portion of the procedure during whichthe surgeon completes the anastomosis of the LIMA to the LAD. The mountof the present invention may be used to facilitate convenientmanipulation of the stabilizer, and other instruments or devices, totheir desired position and allows the devices to be secured in thatdesired position. The retractor of the present invention may be used toprovide access to the anastomosis site of the target artery on the heartitself. Although the LIMA to LAD anastomosis is provided as one example,it is readily appreciated that the techniques and instruments describedherein may be applied to other procedures depending on the clinicaldiagnosis and the patient's anatomy.

[0088] Although each component of the present invention may be usedseparately with great benefit, the components are preferably used inunison to provide a surgical system which provides an unobstructed andorganized surgical field, exceptional instrument maneuverability andaccess to the heart facilitating total revascularization of the heart ifrequired, and effective vessel stabilization during the anastomosisprocedure. Although the present invention will have application whetheraccess to the heart is achieved by way of a full-sternotomy,mini-sternotomy, para-sternotomy, thoracotomy or other known approach,the exemplar embodiments described below will be generally describedwith reference to a coronary artery bypass procedure using a mid-sternalapproach.

[0089] Referring to the figures wherein like numerals indicate likeelements, an exemplar surgical system for performing a mid-sternalsurgical procedure on the beating heart is illustrated in FIG. 1 andincludes retractor assembly 10, mount assembly 20 and stabilizerassembly 30.

[0090] Retractor assembly 11 generally includes a pair of opposingblades adapted to engage opposite sides of a sternal incision, or otherincision, and a drive mechanism constructed to force the blades, andthus the sternum apart. Using the drive mechanism, the sternum may bespread to the desired opening, thus providing the desired access anddirect visualization of the thoracic cavity. If desired, the heart maybe positioned or oriented to best present the target vessels foranastomosis. This positioning may be established, for example, throughthe strategic placement and tensioning of sutures in the pericardialsac, by appropriately placing the patient in the Trendelenburg position,or by using a heart positioner in the form or a strap or pad or thelike.

[0091] Once the target vessel is in the desired position, at least onecomponent of stabilizer assembly 30 is brought into contact with thebeating heart adjacent the target site of the anastomosis. The surgeonthen applies a stabilizing force to the beating heart via the stabilizerassembly 30 which may then be fixed in place, preferably to theretractor assembly 10 by way of mount assembly 20. The stabilizing forcesupplied by the stabilizer assembly substantially eliminates movement ofthe heart in the area of the anastomosis so that the surgeon mayaccurately and efficiently perform the required anastomosis (or othersurgical procedure). After the anastomosis has been completed, thestabilizing force is released and the contacting component of stabilizerassembly 30 is removed from the anastomotic site.

[0092] Each of the principal components, the preferred surgical system,and their methods of use are separately described in detail below. Apreferred retractor is described below with reference to FIGS. 2-12, Apreferred stabilizer or instrument mount according to the principles ofthe present invention is described below with reference to FIGS. 13-32.Preferred stabilizer embodiments according to the principles of thepresent invention are described below with respect to FIGS. 33-44. Apreferred surgical system and methods for performing a coronary arterybypass on a beating heart according to the principles of the presentinvention is described below with respect to FIG. 45.

[0093] The Retractor

[0094] The preferred retractor generally involves a drive mechanism anda pair of opposing blades adapted for insertion into an incision and forengaging opposite sides of the incision. The drive mechanism functionsin some manner to urge the opposing blades apart, thus forcing oppositesides of the incision open to allow surgical access through theincision. For purposes of performing a coronary artery bypass, theincision may be any suitable incision which provides the desired accessto the thoracic cavity, and more specifically a desired area of theheart. For purposes of example only, the retractor of the presentinvention will be described with respect to a mid-sternal incision,however skilled artisans will recognize that many aspects the inventionare equally applicable to other surgical approaches to the heart, forexample, by way of a thoracotomy, or other suitable access approach.

[0095] When the heart is accessed by way of an incision through all or aportion of the sternum, the opposing blades are adapted to be insertedinto and engage opposite sides of a sternal incision such that thesevered sternum may be forced apart by the action of the opposing bladesto create a working space for operating on the heart. Typically, thedrive mechanism is constructed to spread the opposing blades apart in agenerally parallel fashion, however, the parting motion may also have asignificant curvilinear or angular component as well.

[0096] In one embodiment, the blades may be permanently, integrally, orinseparably formed with a drive mechanism. Preferably however, at leasta portion of the blades are separable from the drive mechanism. That is,at least some of the features and functions associated with theretractor blades are allocated to a structural component which isseparate, separable, or otherwise detachable from the drive mechanism.The separate component and the drive mechanism may be manufacturedindependently and then subsequently assembled at the factory or, morepreferably, at the point of use.

[0097] A retractor construction having a separable component allows thefeatures and functions of the drive mechanism to remain separate fromthe remainder of the retractor assembly and vice versa. This allows agreatly simplified or depopulated drive mechanism and allows theseparable component to have a much more sophisticated construction withincreased features and functionality. Accordingly, the simplified drivemechanism, which is typically required to be made from a hardened steel,is easier and more economical to manufacture and easier to maintain,clean and sterilize post surgically. Moreover, the separate componentcan be economically made from materials or processes that allow for theintricate structural features which provide superior functionality.

[0098] In a preferred embodiment, the drive mechanism is constructed tobe resterilized and reused a relatively large number of times, and thefeature-rich separate component is constructed to be disposable, i.e.discarded after a single surgical use. Thus, the depopulated drivemechanism, which will be used over and over, can afford to beconstructed to be quite robust with a view to materials andmanufacturing processes that will support the rigors of such extendedsurgical service. The separable component, free from the typicalfunctional requirements of the drive mechanism and the servicerequirements of extended surgical re-use, may preferably be constructedfrom any number of engineering materials to produce an economicalcomponent having the desired features and which may be discarded after asingle use if desired.

[0099] In a preferred embodiment, retractor assembly 10 comprises adrive 12 and first and second platform blades 14 and 16 detachablyconnected to drive 12, as illustrated in FIG. 2. Preferably firstplatform blade 14 and second platform blade 16 each have one or morechannels or engaging members 18 adapted to engage opposite sides of anaccess incision. Activation of drive 12 forces apart first and secondplatform blades 14 and 16 thereby causing engaging members 18 tocorrespondingly force the incision open to provide access to the desiredsurgical site.

[0100] In the example of a sternal approach to the heart, engagingmembers 18 are adapted to engage each side of the incised sternum toreliably hold and engage the sternum as the sternum is forced open toexpose the thoracic cavity and ultimately the heart. As best seen inFIG. 9, which illustrates a cross-section of second platform blade 16,engaging member 18 is generally in the form of a channel or the like,preferably having a U-shape, curved shape, or other shape suitable forengaging the incised sternum.

[0101] Preferably, engaging member 18 generally has a concave interiorprofile 17 for engaging and holding the sternum and a correspondingconvex exterior profile 19 that is relatively smooth so as not tointerfere with other surgical instruments, snag sutures or create othersuch difficulties. The engaging members 18 are preferably constructed tohave sufficient strength to withstand the loads required to spread thesternum yet maintain a suitably low profile to facilitate easy insertioninto the access incision and to require as little space within theworking incision as possible.

[0102] It may be desirable to provide engaging members 18 with featuresto reduce trauma to the incision site, increase the traction against thesides of the incision, or both. A thin pad or layer of non-slip oratraumatic material (not shown) may be fixed, by way of an adhesive orother suitable fastening technique, to the interior profile 17 ifdesired to reduce slippage and trauma to the severed sternum orsurrounding tissue. Alternatively, the desired features may beintegrally fabricated into engaging members 18. For example, whenplatform blades 14 and 16 are injection molded components, tractionfeatures such as raised bumps, ribs, indentations, or the like can bemolded integral into engaging members 18.

[0103] Referring to FIGS. 2-6, drive 12 is preferably constructed toforce the platform blades apart in generally opposite directions. Anytype of drive mechanism which provides the desired separating action ofthe blades may be suitable. A common, substantially straight-lineparting motion may be provided by a ratchet or rack arrangement as isgenerally known in the art. FIG. 3 illustrates a preferred drive 12which involves a bar 15, moveable housing 22 and handle assembly 24which facilitates movement of moveable housing 22 relative to bar 15. Afirst end of first blade 14 may be operably attached to moveable housing22 and second blade 16 to bar 15.

[0104] In a preferred embodiment, bar 15 is a substantially rigid barhaving a stationary or fixed housing 21 assembled thereto and thusforming bar assembly 23. Fixed housing 21 may be fastened to one end ofbar 15 using one or more mechanical fasteners, an interference fit,suitable adhesive or bonding compounds, welding, or any other suitablefastening technique. A first end of second blade 16 is preferablyoperably attached to fixed housing 21. As with moveable housing 22,fixed housing 21 may be of any configuration which provides for thestructural attachment of first and second platform blades 14 and 16.

[0105] Bar 15 preferably includes a number of teeth 13 evenly spacedalong at least a portion of its length. Teeth 13 may have substantiallyparallel side portions 11 and may have radiused tops 25. The exterioredges of teeth 13 may be broken or radiused or have a chamfer 26 asshown. Handle assembly 24 preferably includes a means for engaging teeth13 so as to drive moveable housing 22 relative to bar 15 to any desiredposition under load where it remains so positioned against the loadwithout need for any applied input or holding force. The means forengaging teeth 13 could be any suitable gear, ratchet, cog or likemechanism. Bar 15 may also be adapted and used for receiving aninstrument mount, such as those described in detail below.

[0106] In a preferred embodiment, moveable housing 22 is driven usingone or more drive pins which may successively engage teeth 13 in acogging manner. Handle assembly 24 includes drive handle 29 connected tofirst and second cylindrical drive bearings 31 and 32. Drive bearing 31preferably has a raised boss 34 extending from one end to which drivehandle 29 may be pivotally connected by way of pin 33. At the oppositeend, drive bearing 31 has first drive pin 27 and second drive pin 28extending therefrom and terminating at second drive bearing 32. Firstand second drive bearings 31 and 32 are spaced apart a distance 35 whichis selected to be slightly greater than the thickness 38 of bar 15 suchthat a portion of bar 15 may be received between first and second drivebearings 31 and 32. The outside diameters of drive bearings 31 and 32are selected so as to fit within guide holes provided in moveablehousing 22. For example, the outside diameter of second drive bearing 32is sized to accurately rotate within guide hole 36.

[0107] Moveable housing 22 has a bore 37 extending therethrough forreceiving bar 15. Bore 37 generally has a shape corresponding to thedimensions of the cross-section of the portion of the bar 15 which is topass through bore 36. With handle assembly 24 properly positioned withinthe guide holes provided in moveable housing 22, it may be assembled tobar 15 by placing the end of bar 15 within bore 36 and turning handle 29such that first and second drive pins 27 and 28 become engaged withteeth 13. Once assembled in this manner, moveable housing 22 may beforced one way or the other along the length of bar 15 by turning handle29, and thus drive bearings 31 and 32, to cause first and second drivepins 27 and 28 to progressively engage teeth 13 along bar 15.

[0108] As mentioned above, first and second platform blades 14 and 16may be removably assembled to moveable housing 22 and fixed housing 21,respectively. Platform blades 14 and 16 may be attached in any suitablefashion including, for example, threaded connections or other matingfeatures on the platform blades and housings themselves, ordinary orspecialized mechanical fasteners, and cam or latching mechanisms adaptedto secure the platform blades to the housings. In a preferredembodiment, both moveable housing 22 and fixed housing 21 areconstructed with features that engage, secure and support first andsecond platform blades 14 and 16 in an operable position on drive 12,thus providing an assembled retractor 10 which is ready for surgicaluse.

[0109] Referring to FIGS. 7 and 8, second platform blade 16 is shownbefore and after assembly onto fixed housing 21. Preferably, at leastone of the platform blade 16 or the fixed housing 21 has an extendingprotuberance, post or like feature which can be receivably engaged bythe other of the platform blade or housing. In a preferred embodiment,fixed housing 21 is preferably constructed to have a latch post 42adapted to be received within latch post cavity 45 provided in platformblade 16. Latch post 42 may have a hole, notch, protuberance, or otherfeature formed therein which may be engaged in any convenient manner bythe platform blade 16 so that platform blade 16 becomes releasablylocked in place for use.

[0110] In a preferred embodiment, latch post 16 has a notch whichdefines latch surface 51 and stop surface 52. Platform blade 16 has alatch member 48, best seen in FIGS. 11A-11C, having a latch body 50constructed with surfaces 53 and 54 for engaging latch surface 51 andstop surface 52 respectively. Generally transverse to latch post cavity45, platform blade 16 has a latch body cavity 56 having an openingtowards upper surface 57 of platform blade 16 for receiving latch body50 of latch 48.

[0111] Latch 48 is preferably constructed to engage and disengage latchpost 42 by manual rotation of latch knob 49. Latch body 50 includescylindrical portion 55 which provides for controlled rotation withinlatch body cavity 56. Latch body 50 may be biased towards the engagedposition shown in FIG. 8 by way of any suitable spring element.Preferably, latch post 42 is provided with an angled tip 43 having alead-in angle 44 which allows angled tip 43 to slide against secondengaging surface 54 as latch post 42 begins to be received within latchpost cavity 45. As latch post 42 is advanced further within latch postcavity 45, angled tip 43 causes latch 48 to rotate out of the way aboutcylindrical portion 55. Near the end of the advancement of latch post 42within latch post cavity 45, the angled tip is advanced beyond latchbody 50, and latch 48 (which is biased towards an engaged position)rotates into the engaged position with second engaging surface 54 biasedagainst stop surface 52.

[0112] With latch 48 and latch body 50 snapped into the engagedposition, any separating force encountered between platform blade 16 andfixed housing 21 is resisted by action of first engaging surface 53against latch surface 51. With this configuration, the reaction force atfirst engaging surface 53 is advantageously borne by latch body 50primarily in compression. Thus, since the loading is primarilycompressive in nature, a high strength material is not required, andlatch 48 can be made from standard engineering polymers, for example,such as polycarbonate.

[0113] When it is desired to remove platform blade 16 from drive 12, theoperator simply turns latch knob 49, causing latch body 50 to be placedin a disengaged position relative to latch post 42. With latch 48disengaged, latch post 42 of fixed housing 21 is free to be removed fromlatch post cavity 45 of platform blade 16. As is apparent from theFigures, a mirror image of the latch assembly described with referenceto platform blade 16 and fixed housing 21 is provided to releasablyattach platform blade 14 to moveable housing 22.

[0114] When the retractor assembly is used to gain access to thethoracic cavity, a good deal of force must be generated to create thedesired opening. For example, a separating force in excess of 100 poundsmay be required to be generated at each engaging member 18 to achievethe desired separation of a particular sternum. Such loads must becarried by the engaging members and transmitted to drive 12 by way ofplatform blades 14 and 16. Since platform blades are preferably madefrom a suitable engineering polymer (for example, a glass filledthermoplastic polyurethane resin), it may be desirable to provide areinforcing member for each of platform blades 14 and 16 to ensure thatplatform blades 14 and 16 will not break or otherwise renderedinoperable as a result of the loads encountered during use.

[0115] Although the reinforcing members may be a permanent or removablemembers within the platform blades themselves, the reinforcing membersare preferably one or more substantially rigid members extending fromeach of the fixed housing 21 and the moveable housing 22. In a preferredembodiment, fixed and moveable housings 21 and 22 have a pin extendingtherefrom which may be received within a mating cavity within first andsecond platform blades 14 and 16. The pin operates to spread the loaddeveloped in the mechanism over a larger internal area within theplatform blades 14 and 16 and reduces the effective beam length ofunreinforced platform blade material subjected to the operating loads.The pin may be straight pin 40′ illustrated in FIG. 3. More preferably,fixed and moveable housings 21 and 22 have tapered pins 40 and platformblades 14 and 16 have mating tapered cavities 41 for receiving taperedpins 40.

[0116] The tapered construction tends to allow the user to easily alignpin 40 with cavity 41 and allows the pins 40 to fit relatively snuglywithin cavities 41 without significant binding during insertion thatcould otherwise occur between elongate pins and mating cavities whichare designed to be very close fitting.

[0117] To provide sufficient load bearing reinforcement, the reinforcingpins 40 are preferably constructed of a substantially rigid material,such as steel, and are preferably at least about 0.75 inches long, morepreferably at least about 1.125 inches long, and most preferably betweenabout 1.25 inches to about 2.25 inches long. In a preferred embodiment,reinforcing pins 40 are made from AISI 420 stainless steel having alength of about 1.5 inches, an outside diameter near the housing ofabout 0.25 inches, and a 2 degree taper angle decreasing towards thefree end of the reinforcing pins 40.

[0118] In the preferred embodiments just discussed, platform blade 16can be removed from drive 12 with a substantially straight-line relativemotion as indicated by arrow 46. This engagement action not onlyprovides for simple and intuitive assembly in the operating room, butalso represents a significant safety feature. Under certain rarecircumstances, for example where the drive through neglect or misuse hasbecome sufficiently damaged during use that it is unable to close anddisengage from the sternum, an extremely dangerous situation can becreated for the patient. In such exigent circumstances, theconfiguration described above may allow the drive to be separated fromthe in situ platform blades by releasing the latches and applying asufficient amount of force in the direction indicated by arrow 46. Oncethe drive has been removed, the detached platform blades may be easilyremoved from the patient.

[0119] In addition to engaging members 18, detachable platform blades 14and 16 may incorporate a wide variety of additional features whichenhance the performance of the retractor system. For example, one orboth of platform blades 14 and 16 may have mounting features to whichvarious instruments used during the procedure can be secured. In thecase where a stabilizer is to be secured to a retractor for operating ona beating heart, it is critical to minimize or substantially eliminatethe amount of flex and motion attributable to each component and eachconnection between each component, from the component engaging thebeating heart to the component which provides the sternal attachment. Tothis end, the engaging features 18 which engage the sternum arepreferably part of a unitary platform blade structure which alsoincludes mounting features to which a stabilizer and other instrumentscan be mounted. Since the mounting features and the sternal engagingfeatures are part of the same component, and therefore there is nomechanical connection between the two, the stability of an attachedinstrument against the forces of a beating heart is greatly improved.

[0120] In a preferred embodiment, each of first and second platformblades 14 and 16 include mount features in the form of rails. The railsallow one or more instruments to be positioned at any desired locationalong the operable length of the rail. Preferably, the rails areoriented in a direction generally perpendicular to the direction ofseparation, in this case perpendicular to bar 15. The rails may be arecessed feature within the body of platform blades 14 and 16. Morepreferably, the mounting rails extend upwardly from the body of platformblades 14 and 16.

[0121] Referring to FIGS. 7-9, right platform blade 16 has rail 60extending over at least a portion of the length of platform blade 16.Rail 60 may have a top portion and a bottom portion having a narrowedregion adjacent said top portion. In one embodiment, Rail 60 preferablyhas a T-shaped cross-section. The T-shaped configuration has a topportion 61 and a narrowed portion 62, thus forming mounting tabs 63 and64 which can be gripped by a number of appropriately constructed mounts.

[0122] The rail may be straight, curved, or a combination of straightand curved portions. Preferably, at least a portion of the T-shaped railis curved in a manner which more closely follows the profile of theaccess or incision site (as seen, for example, see FIG. 45). In a curvedrail configuration, instruments extending perpendicular to a generallycentral axis 67 of rail 60 will naturally point more towards a centralarea between the platform blades 14 and 16, and thus may require lesspositional adjustment or manipulation from their normal, natural orbeginning position. In addition, all or a portion of top portion 61, andmore specifically mounting tabs 63 and 64, may be tilted or angledinwardly at an angle 65 as shown.

[0123] Platform blade 16 may be also be provided with a number of sutureholders or stays which can be used to organize or capture varioussutures used in the course of a particular surgery. Since certainsutures are placed near the beginning of a CABG procedure, such aspericardial sutures used to position the heart, the placement of thesuture stays in a manner which does not interfere with subsequentprocedures and instruments is an important aspect of the presentinvention. Preferably, the suture stays are positioned such that placingand manipulating the sutures or the various instruments and instrumentmounts employed during surgery can be accomplished without interferingwith each other. Preferably, the location of the suture stays positionthe sutures below the level of the mounting tab 63 and 64 so that amating instrument mount may traverse the entire operable length of rail60 without interfering with the sutures.

[0124] Rail 60 may have one or more grooves, channels, slots orpassageways for receiving a suture. In addition, a suture lock may beprovided in the rail or elsewhere on platform blade 16 so that thesuture may be fixed in place. To accommodate the use of pericardialsutures, which are often subjected to a significant amount of tensionwhen used to position the heart, the suture locks must be adapted tohold the suture material even while under a significant amount oftensile loading.

[0125] In a preferred arrangement for organizing and locking sutures,and in particular tensioned pericardial sutures, rail 60 has at leastone open slot or passageway formed therein for receiving the free endportions of a surgically placed suture. The passageways preferablyextend across rail 60 and have a depth which allows the suture to lay atan elevation sufficiently below mounting tabs 63 and 64 so as not tointerfere with an instrument mount sliding along rail 60. In a preferredembodiment the passageways extend through at least a portion of narrowedportion 62. Thus, the height 66 of narrowed portion 62 may be selectednot only to provide sufficient space for a desired instrument mount toattach, but also to ensure that mounting tabs 63 and 64 are sufficientlyraised above the surrounding features of platform blade 16 so that aninstrument mount may be positioned and repositioned along rail 60without disturbing or disrupting the sutures within the variouspassageways.

[0126] The passageways may be a single channel for receiving both freeends of a surgically placed suture or each end may have a separatechannel. In a preferred embodiment, rail 60 has a number of bifurcatedchannels 70 at predetermined intervals along its length. Referring toFIG. 10, bifurcated channel 70 has a single entrance channel 71 whichbifurcates into first and second exit channels 72 and 73. Entrancechannel 71 and either one of exit channel 72 or 73 can be used in thesame manner as a single channel, with both free ends 76 and 77 beingrouted together. Alternatively, both suture ends may be received withinentrance channel 71 and then separated, one end within exit channel 72and one end within exit channel 73.

[0127] A means for clamping the suture against movement within thesuture channels may be provided on any of entrance channel 71 or exitchannels 72 or 73. Preferably, suture locks are provided on each exitchannel 72 and 73. This allows the surgeon to positively identify andunlock a desired suture end for further tension adjustments or othermanipulation without unlocking or loosening the other end of the suture.In addition, placing each suture end 76 and 77 in separate exit channels72 and 73, each with a dedicated suture lock, increases the maximumamount of tension that can be applied to a given suture. Exit channels72 and 73 may have recesses 74 and 75, respectively associated therewithfor receiving a suture lock adapted to secure the suture material withinthe channels.

[0128] A preferred suture lock 80 is illustrated in FIGS. 10 and 12.Suture lock 80 has a relatively rigid body 83 having a fixed or pivotend 81 which allows body 83 to pivot within the mating profile of recess74 or 75. Pivoting the body 83 about pivot end 81 selectively engagesand disengages free end 84 against the wall 78 of exit channel 72 or 73.Alternatively, suture lock 80 may be made from a more flexible materialwhich, by nature of the elastic properties of the material, tends toflex about its fixed end instead of rotate. In a preferred embodiment,fixed or pivot end 81 is substantially cylindrical and recesses 74 and75 have mating cylindrical surfaces.

[0129] Preferably, the suture lock is angled relative to the wall 78 sothat it is self-locking in one direction. That is, the suture ends 76 or77 (or both) operate on the free end 84 in such a way as to force ittowards wall 78, and thus against the suture material, in proportion tothe tension, T encountered by suture ends 76 or 77. Thus, withinpractical limits, the higher the tension the harder free end 84 willpress or bite against the sutures placed therein. Conversely, when thesuture ends are pulled in the direction indicated by arrow 79, thesuture forces tend to pivot body 83 about pivot 81 such that free end 84is rotated away from wall 84 allowing the suture to move relativelyfreely. Preferably, angle 79 between body 83 and wall 78 is nominallyabout 1 degree to about 30 degrees, more preferably about 5 degrees toabout 15 degrees, most preferably about 10 degrees. Of course, angle 79is greater as body 83 pivots to accept a suture placed within the suturechannel.

[0130] Suture lock 80 may be biased towards the locked position,preferably using a small spring between the suture lock and the recess75. In a preferred embodiment, a piece of resilient closed cell foam 85is fixed to body 83 to provide the desired biasing effect. Free end 84may optionally have a number of teeth or ridges 82 to ensure acceptabletraction against the suture material.

[0131] Platform blades 14 and 16 may also be provided with soft tissueretainers to help control and retain the incised tissue and fat in theimmediate vicinity of the blades. Referring to FIGS. 8 and 9, platformblade 16 includes integrally attached tissue retainer 85. Tissueretainer 85 is generally at a small distance 88 above the top of theengaging members 18. Tissue retainer 85 may be made from a flexiblematerial, such as an elastomer, preferably a polyurethane elastomerhaving a durometer in the range of about 45 to about 75 Shore D, morepreferably about 55 Shore D. In a preferred embodiment tissue retainer85 is injection molded over the platform blade to form a permanent andinseparable assembly. Tissue retainer 85 may have a raised outer lip 86and optionally having a plurality of slots 87 formed therein to receiveand organize any loose suture ends. Tissue retainer 85 ensures that thetissue surrounding the access incision does not interfere with theoperation of rail 60 or the suture holders and also provides aconvenient location for attaching surgical drapes of the like withoutinterfering with the operation of the retractor assembly.

[0132] Although some of the features of the present invention have beendescribed, for illustration only, with respect to only one of theplatform blades 14 and 16, it should be apparent that both platformblades 14 and 16 may have similar or identical features. Although notnecessarily so, first platform blade 14 and second platform blade 16 arepreferably substantially mirror images of each other.

[0133] The retractor assembly just described, provides a simplifieddrive mechanism for use in conjunction with multi-featured platformblades. In addition, a number of different platform blades may beprovided for use with a single drive, for instance, tailored todifferent sized anatomy or the specifics of different surgicalprocedures. Thus, a number of platform blade configurations can beprovided to an operating room and, based upon pertinent prevailingclinical factors, the proper configuration can be selected, mounted todrive 12, and used as described above to provide access to a desiredlocation. Also, with the modular configuration new features andadvancements can be rapidly incorporated into the platform blades andimmediately introduced for use with existing simplified drives alreadyin place in the operating rooms.

[0134] The platform blades themselves represent a surgical platform thatallows instruments to be mounted and stabilized in virtually anyposition, even over already placed and secured sutures from the surgicalsite accessed by the retractor assembly. Described below are preferredinstrument mounts for use in conjunction with rail 60 to secure abeating heart stabilizer or other instruments such as heart positioners,saline or medical air blowers, suction devices, surgical clamps, orvessel occluders.

[0135] The Instrument Mount

[0136] Referring to FIG. 13, a preferred instrument mount assembly 20 isshown for mounting an instrument, such as stabilizer assembly 30, to aninstrument mounting rail such as described above with respect to rail 60of platform blades 14 and 16. Mount assembly 20 includes mount base 115having features to secure mount assembly 20 at a desired position on anappropriately configured mating rail or other suitable structure andincludes a shaft locking mechanism for controlling and securing aninstrument shaft in a desired position and orientation.

[0137] One important aspect of instrument mount assembly 20 is toprovide the necessary degrees of freedom to allow the tissue stabilizeror other instrument to be easily maneuvered to whatever position may berequired by a particular procedure. As discussed above, an additionalaspect with respect to stabilizing the beating heart is to eliminate orminimize the flex or motion attributable to the various components andconnections of instrument mount assembly 20. As will be discussed inmore detail below, instrument mount assembly 20 is uniquely suited foruse in stabilizing the beating heart because it allows sufficientdegrees of freedom to easily manipulate the position of an instrumentsecured thereto, allows the degrees of freedom to be frozen or locked inplace and, once locked in place, does not significantly flex or allowmovement at any of the mechanical joints or connections.

[0138] Instrument mount assembly 20 provides a number of differentcontrollable joints that, when in a released condition, allows motion inone or more predetermined directions or about one or more degrees offreedom. Although instrument mount assembly 20 may be used to secure anymounting shaft configuration from straight or curved substantially rigidshafts to multi-link or segmented ball and socket type shafts which arerelatively flexible until themselves locked in some manner at each jointalong the shaft length, it is most advantageously constructed to providethe joints or connections required to position an instrument having astraight or curved rigid shaft.

[0139] In a preferred embodiment, instrument mount assembly 20 has threereleasable joints or connections for controlling the location andposition of the instrument mount assembly and instrument attachedthereto. The mount base may be positioned at a desired location along anappropriate rail and secured by rail grips 114 and 116. The position andorientation of the instrument is then determined by ball joint (or balland socket joint) 112 between mount base 125 and mount body 110, arotational joint 157 between mount body 110 and shaft hub assembly 160,and a shaft clamping mechanism within shaft hub assembly 160 which mayallow translation, rotation, or both of shaft 3 relative to shaft hubassembly 160.

[0140] Ball joint 112 is preferably of the ball and socket type having 3rotational degrees of freedom. Rotational joint 157 allows rotation ofshaft hub assembly 160 about axis 121 as indicated by arrow 113. Theshaft clamping mechanism allows translation of instrument shaft 3 asindicated by arrows 111 as well as rotation about the shaft itself asindicated by arrow 117. As will be discussed later, a further ball-jointtype connection 201 may be employed between shaft 3 and the particularend-effector of the instrument.

[0141] Instrument mount assembly 20, having the particular joints andconnections identified above, allows all the required areas of the heartto be conveniently and intuitively accessed by a stabilizer connected toone end of a substantially rigid shaft. Certainly, instrument mountassembly 20 could be provided with more or less degrees of freedom formaneuvering a particular instrument. For example, to add additionaldegrees of freedom rotational joint 157 could be replaced with a balljoint and to eliminate degrees of freedom shaft 3 could be keyed withinshaft hub assembly 160 or ball joint 112 could be replaced with arotation only joint. However, it should be noted that excessive degreesof freedom may tend to make instrument adjustment increasingly difficultand cumbersome to control while too few degrees of freedom may not allowthe instrument to be easily placed in the desired position ororientation.

[0142] In one embodiment, the various joints and connections are lockedinto a desired position by way of a series of knobs. The degrees freedomprovided by ball joint 112 is locked by activation of top mount knob120. Both rotational joint 157 and the shaft clamping mechanism of shafthub assembly 160 is locked in place by the activation of side mount knob118. Base 125 is locked in position on the rail by activation of mountlever 122. Ball joint 201, as will be discussed in greater detail below,may be locked in position by activation of knob 504. This particularsequence of knobs used to lock down the degrees of freedom associatedwith instrument mount assembly 20 tends to allow the user greaterprecision in positioning the instrument because degrees of freedomunnecessary to a particular desired maneuver of the instrument can belocked down.

[0143] Most commonly, mount body 110 is placed at a desired angle ororientation and then fixed in place by locking ball joint 112, leavingfinal adjustment to take place using rotational joint 157 and the shaftmovement allowed by the shaft clamping mechanism of shaft hub assembly160.

[0144] FIGS. 14-20 show in greater detail the various mechanisms whichlock and release the joints or connections associated with instrumentmount assembly 20. FIG. 14 shows an exploded assembly illustration ofinstrument mount assembly 20. Instrument mount assembly 20, and morespecifically mount base 125 to which all the other components areultimately secured, is preferably constructed to engage and lock inposition on a rail or other suitable feature.

[0145] Preferably, instrument mount assembly 20 has a fixed rail grip114 adapted to engage mounting tab 64 of rail 60 and a moveable railgrip 116 adapted to engage mounting tab 63 or rail 60. Rail grips 114and 116 may generally have hook-like features for gripping mounting tabs63 and 64. Rail grip 114 is part of mount base 125 and moveable railgrip 116 is part of articulating hinge member 115, which is pivotallyattached to mount base 125 by way of hinge pins 123 and 124, or othersuitable fastener. Articulation of hinge member 115 and rail grip 116 inclamping manner towards rail grip 114 on mount base 125 effectivelyclamps mount base 125 onto rail 60 at mounting tabs 63 and 64.

[0146] Hinge member 115 may be articulated using any suitable mechanismcapable of pivoting hinge member 115 to a closed position and holding itthere. In a preferred embodiment, best illustrated in FIGS. 15A-17,hinge member 115 includes follower surface 155 which may be acted uponby any suitable cam device to drive hinge member 115 about hinge pins123 and 124, thus urging rail grip 116 towards rail grip 114.

[0147] In a preferred embodiment, hinge member 115 is articulated byaction of cam 145 having cam surface 152 which acts upon followersurface 155. Cam 145 has a center, C about which cam 145 rotates.Preferably, cam 145 has bore 127, having its central axis coincidentwith center, C. Mount base 125 may have a cam guide 153 around whichbore 127 rides for smooth rotation of cam 45 about center, C. Camsurface 152 has a varying radius, illustrated by exemplar radial linesR₁, R₂, R₃, R₄, and R₅. Thus as cam surface 152 is rotated past followersurface 155, from example from R1 to R2, it pushes the follower surfacea greater distance away from center, C, thus causing hinge member 115 topivot about hinge pins 123 and 124, thus causing rail grip 116 to movecloser to rail grip 114.

[0148] The varying radius of cam surface 152 may be configured to placehinge member 115, and thus rail grip 116 in a variety of positions. Afirst portion of cam surface 152 may be configured such that followersurface 155 biased against cam surface 152 is placed in an positioncharacterized in that rail grip 116 is sufficiently spaced apartrelative to rail grip 114 to allow assembly onto a rail or otherstructure. A second portion of cam surface 152 has an increasing radiussuch that rotation of cam 145 moves rail grip 116 towards rail grip 114to an intermediate position. In the intermediate position, rail grip 116has been moved close enough to rail grip 114 so that it becomes capturedon a rail but remains loose enough to slide along the rail. A thirdportion of cam surface 152 has an increasing radius such that therotation of cam 145 moves rail grip 116 further towards rail grip 114 toa completely locked position wherein relative motion between rail grips114, 116 and the rail is essentially no longer possible.

[0149] Cam 145 is generally provided with a handle or lever 122 to allowthe user to easily turn cam 145 relative to mount base 125. Cam 145 maybe captured onto mount base 125 by operation of retaining hook 150 oncam 145 which rides within exterior groove 151 on mount base 125 on oneside, and projection 154 which is engaged below undercut 156 generallyopposite to retaining hook 150. Projection 154 also serves to workagainst undercut 156 to return hinge member 115 to the open position ascam 145 is rotated in the opposite (open) direction. Hinge member 115preferably has first and second end stops 158 and 159 between which themotion of projection 154 (and thus the rotation of cam 145) is limited.Cam 145 may also have a protective extended portion or cover 163 whichshields the area of groove 151 when assembled over mount base 125.

[0150] The assembly of cam 145 and hinge member 115 to mount base 125 isillustrated in FIGS. 15A and 15B. Cam 145 is placed in position relativeto hinge member 115 with projection 154 in place below undercut 156. Inroughly that position, cam 145 and hinge member 115 are brought overmount base 125 until bore 127 is properly seated over cam guide 153 andretaining hook 150 is positioned within groove 151. Pins 123 and 124 arethen pressed in place through holes provided in both mount base 125 andhinge member 115.

[0151] Ball joint 112 is generally created between ball 129 provided atthe top of mount base 125 and a socket or mating cavity within mountbody 110 adapted to receive at least a portion of ball 129. Preferablyball 129 includes a generally spherical portion, although other curvedshapes providing the desired degrees of freedom may also be suitable.Base post 130 extends vertically upward through bore 126 of mount base125 and vertical passageway 128 of mount body 110 until enlarged endportion 130 become biased against mount base 125. Top mount knob 120 maythen be threaded onto threaded shaft 132 whereby mount base 125 andmount body 110, with ball 129 received within mount base 125, becomescaptured between top mount knob 120 and enlarged end portion 130.Continued tightening of top mount knob 120 over threaded shaft 132forces ball 129 harder against mount body 110 until the friction betweenmating surfaces on ball 129 and mount body 110 become so great as toeffectively resist any relative movement, thus locking ball joint 112.

[0152] The assembly of rotational joint 157 and shaft hub assembly 160are shown in FIG. 19. Rotational joint 157 is in the form of a conicalclutch formed between frustoconical surface 138 of clutch member 135 andmating frustoconical surface 139 in mount body 110. Shaft hub assembly160 is generally formed as upper and lower shaft locks 136 and 137 areadvanced over shaft grip 140 and against instrument shaft 3 which ispositioned between shaft locks 136 and 137 and outer shaft guide 144. Asclutch member 135 is received over the outside diameter of grip housing141 of shaft grip 140 tang 164 becomes engaged between upper shaft lock136 and lower shaft lock 137 thereby preventing relative rotationbetween clutch member 135 and shaft grip 140.

[0153] Side mount knob 118 having threaded shaft 119 extends throughmount body 110 (and consequently through transverse bore 131 in centralportion 167 of base post 130), clutch member 135 and into interiorthreads 142 within grip housing 141 of shaft grip 140. Tightening ofside mount knob 118 clamps the assembly together. Thus, translation androtation of instrument shaft 3 is prevented as shaft grip 140 and clutchmember 135 are forced together to clamp or trap instrument shaft 3between shaft locks 136 and 137 and outer shaft guide 144. Also,relative rotation between frustoconical surface 138 of clutch member 135and mating frustoconical surface 139 in mount body 110 is prevented asclutch member 135 is forced against mount body 110. One or both offrustoconical surface 138 and mating frustoconical surface 139 mayinclude a number of teeth, ridges, or other features to prevent rotationwhen clutch member 135 is forced against mount body 110.

[0154] So that the shaft does not become too loose as side mount knob118 is loosened, a minimum amount of friction between instrument shaft 3and the clamping surfaces 146 of outer shaft guide 144 is preferablymaintained by providing a biasing load against shaft 3. Referring toFIG. 20, shaft biasing member 147 is provided within shaft grip 140 tomaintains a biasing load against shaft 3. Shaft biasing member 147 has afirst portion 148 which slides within counterbore 143 in shaft grip 140.Shaft biasing member 147 may optionally have a second portion 149 havingexternal dimensions sized to be received within the inside diameter ofcompression spring 133. Compression spring 133 urges end 134 of shaftbiasing member 147 against shaft 3 to force shaft 3 against clampingsurfaces 146. The amount of force is selected to allow instrument shaft3 to be easily positioned by hand but would generally not allowinstrument shaft 3 to slide relative to shaft grip 140 under only itsown weight.

[0155] Referring to FIG. 21 a preferred instrument mount assembly 20 isshown fixed to a preferred platform blade 16 having rail 60. Asdiscussed above, rail 60 has mounting tabs 63 and 64 over which railgrips 114 and 116 may be secured. Instrument mount assembly 20 can bepositioned, maneuvered, and removed virtually anywhere along rail 60without disturbing suture 166 locked in place by free end 84 of suturelock 80 below the operating features of instrument mount assembly 20within any one of the suture channels provided in platform blade 16. Inaddition, rail 60 is placed in close proximity to engaging member 18 andthus close to the surgical opening into the patient providing a moredirect access to the heart by an instrument mounted to instrument mountassembly 20. Since the rail 60 moves in unison with platform blade 16,this relationship between rail 60 and engaging member 18 is maintainedno matter how much or how little platform blades 14 and 16 have beenspread to create the desired surgical opening.

[0156] FIGS. 22A-32 illustrate a preferred embodiment of an alternativeinstrument mount assembly 220. Preferably, the degrees of freedomavailable for maneuvering instrument mount 220 is substantially the sameas that of instrument mount assembly 20. Instrument mount assembly 220preferably has ball joint 112 between mount base 221 and mount body 222,a rotational joint 157 between mount body 222, and a shaft hub assembly227 which allows rotation and translation of an instrument shaft heldbetween shaft grip 226 and clutch member 226 of shaft hub assembly 227.Instrument mount assembly 220, however, has a different mechanism forcontrolling or locking the various joints and connections and may alsoprovide a means for releasing and removing the shaft from the bulk ofthe remainder of instrument mount assembly 220.

[0157] As just mentioned, the joints and connections themselves arequite similar between instrument mount assemblies 20 and 220. As before,ball joint 112 is a ball and socket configuration created betweengenerally spherical ball 224 provided at the top of mount base 221 and amating cavity within mount body 222 adapted to receive and slide againstat least a portion of ball 224. Rotational joint 157 may be in the formof a conical clutch formed between frustoconical surface 243 of clutchmember 225 and mating frustoconical surface 244 in mount body 222. Aninstrument shaft may be clamped in place within shaft hub assembly 227by forcing together shaft grip 226 and clutch member 225 thus closingclamp surface 239 of outer shaft guide 233 towards V-shaped channels 273on shaft locks 231 and 232.

[0158] Instead of locking the joints and connections by way of multipleknobs as described above with respect to instrument mount assembly 20,instrument mount assembly 220 preferably uses a mechanism which releaseseach of ball joint 112, rotational joint 157, and the shaft clampingmechanism of shaft hub assembly 227 by activation of a single knob,lever, or other suitable manual interface. Generally speaking, this isaccomplished by utilizing the clamping motion required to lock one ormore of the joints or connections along a first axis to also lock theremainder of the joints or connections along remaining axes.

[0159] In a preferred embodiment, ball 224 of mount base 221 is lockedin place relative to housing 222 by operation of base post 230. Basepost 230 is assembled through mount base 221 and mount body 222 from thebottom until bottom flange 259 (see FIG. 27) is resisted against mountbase 221. At the top of base post 230 is upper link portion 256 havingpivot hole 257. Cam 235 is attached through pivot hole 257 at off-centerlink pivot 238 using a pin or other suitable fastener and is supportedby contact surface 236 associated with mount body 222. Contact surface236 may be an integral feature of mount body 222 or may be in a separatemount body cover 254 which may be selected to have superior wearcharacteristics.

[0160] With cam 235 in a closed position, as shown in FIG. 24, linkpivot 238 is drawn to its maximum distance 251 (or slightly less thanthe maximum if the cam is constructed to rotate over center) fromcontact surface 236 thus increasing the clamping force between mountbody 222 and ball 224 as the assembly is clamped between cam 235 on thetop and bottom flange 259 on the bottom. With cam 235 in the closedposition, ball joint 112 is effectively locked.

[0161] By rotating cam 235, by way of handle 237, to an open position asillustrated in FIG. 25, link pivot 238 is withdrawn to a position closerto contact surface 236 at a distance 252, thus reducing or relaxing theclamping forces between mount body 222 and ball 224 of mount base 221.With cam 235 in the open position, the friction at ball 224 is reducedto a level that allows the user to easily manipulate mount body 222relative to mount base 221.

[0162] Mount base 221 may have an insert 253 secured in the bottomthereof against which bottom flange 259 is caused to seat as upper linkportion 256 is drawn upwards by operation of cam 235. Preferably, insert253 includes recess 255 for receiving compression spring 248 capturedabout base post 230. Compression spring 248 operates between insert 253,and thus mount base 221, and bottom flange 259 to bias base post 230towards the unlocked position.

[0163] That same motion of base post 230, created by operation of cam235, is preferably also used to lock both rotational joint 157 and theinstrument shaft clamping mechanism of shaft hub assembly 227. Insteadof using a threaded shaft to clamp instrument mount assembly along thisaxis as did the previous embodiment, instrument mount assembly 220preferably utilizes tie pin 240 which is driven in the direction ofarrow 245 causing shaft grip 226 and clutch member 225 to be forcedtogether to clamp an instrument shaft placed therein and also causingfrustoconical surface 243 of clutch member 225 to forced againstfrustoconical surface 244 in mount body 222.

[0164] Tie pin 240 preferably has a generally cylindrical back portion261 and a front portion which is connected in some manner to shaft grip226. Preferably, the front portion includes forward extending first andsecond flexible prongs 262 and 263. Cylindrical back portion 261 isslidably received within blind hole 272 of release button 242 and ispreferably biased in the unlocked direction indicated by arrow 270 bycompression spring 247 positioned within blind hole 272 behind tie pin240.

[0165] Tie pin 240 is preferably driven in the direction of arrow 245 bythe movement of base post 230 which is assembled in the space betweenfirst and second prongs 262 and 263 of tie pin 240. Preferably, basepost 230 has an angled cam or ramp 258 that engages back wall 269 at thebase of first and second prongs 262 and 263. As base post 230 is drawnupwards in the direction of arrow 271 by cam 235 from the open positionof FIG. 25 to the closed position of FIG. 24, ramp 258 progressivelyforces back wall 269, and thus tie pin 240, in the direction ofindicated by arrow 245.

[0166] Tie pin 240, connected at its front end to shaft grip 226, locksan instrument shaft in place and locks rotational joint 157 in the samemanner as did threaded shaft 119 of instrument mount assembly 20. Insum, tie pin 240 urges shaft grip 226 towards clutch member 225 andmount body 222. The movement of shaft grip 226, having tang 236 engagedbetween upper and lower shaft locks 231 and 232 of clutch member 225,closes together in a clamping fashion surfaces 239 on shaft grip 226 andV-shaped channels 273 on clutch member 225. At the same time, shaft grip226 pushes against clutch member 225 to force frustoconical surface 243against mating frustoconical surface 244 with sufficient force tofrictionally lock the surfaces together, thus preventing relative motiontherebetween.

[0167] The operation of cam 235 has been described as generally movingbetween an open position, in which the various joints and connections ofinstrument mount assembly 220 are free to be easily manipulated abouttheir respective degrees of freedom, and a closed position in which thejoints and connections resist any relative movement and are thuseffectively locked in position. However, the outer cam profile of cam235 operating against contact surface 236 may be given a profile thathas one or more intermediate positions such that link pivot 238 isplaced at an intermediate distance from contact surface 236. In anintermediate position, the joints and connections may be in a stiffenedor partially locked state which allows some positional and orientationalmanipulation with somewhat higher operator forces that the completelyreleased condition. In addition, the action of base post 230 may be suchthat ball joint 112 becomes fully locked before tie pin 240 hascompletely locked the remaining degrees of freedom. Thus, cam 235 mayhave a completely released position where manipulation about all degreesof freedom is easily accomplished, an intermediate position in whichonly ball joint 112 is fully locked and the remaining degrees of freedomare unlocked or may be partially locked, and final closed position inwhich all degrees of freedom are locked.

[0168] Instrument mount assembly 220 may optionally be provided with arelease mechanism allowing shaft grip 226, and thus the instrument shaftslidably assembled therein, to be released from instrument mountassembly 220 preferably by activation of release button 242. This allowsinstruments associated with instrument mount assembly 220 to be quicklyand conveniently removed and replaced or exchanged.

[0169] In a preferred embodiment, first and second prongs 262 and 263 oftie pin 240 have first and second projections 267 and 268 whichreleasably attach tie pin 240 to shaft grip 226. Grip housing 274 ofshaft grip 226 is covered with a sleeve having a deep counterbore 278and small through hole 279. The depth of counterbore 278 is longer thanthe exterior of grip housing 274 so as to form internal space 290 (seeFIG. 25) when assembled. First and second prongs 262 and 263 can beflexed to position projections 267 and 268 relatively close together forinsertion through hole 279 where projections 267 and 268 can then expandapart locking projections 267 and 268 behind surface 280.

[0170] Preferably, projections 267 and 268 have lead-ins 291 and 292which urged projections 267 and 268 together as they are advancedthrough hole 279 so that shaft grip 226 can simply be aligned withlead-ins 292 and 292 and then snapped into place without any furtheraction. Alignment of hole 279 is generally quite simply accomplished asthe cylindrical exterior surface 277 of sleeve 260 is slidably receivedin a substantially coaxial arrangement within center bore 219 of clutchmember 225. Clutch member 225 may optionally have first and secondflexures 281 and 282 having first and second retaining features 283 and284 so that it may be snapped in place and thereafter retained withinmount body 222.

[0171] As mentioned above, shaft grip 226 may be released from tie pin240. To separate tie pin 240, it is necessary to flex first and secondprongs 262 and 263 together so that projections 267 and 268 will againbe positioned to fit through hole 280. This may be accomplished byproviding a raised portion 264 having a ramp 266 on tie pin 240. Asliding member may be advanced up tie pin 240 and over ramp 266 andraised portion 264 thus flexing prongs 262 and 263 inwards. Preferably,the sliding member is a tip portion 289 of release button 242. Tie pin240 is slidably received within blind hole 272 of release button 242.The internal diameter of blind hole 272 is small enough so that when itis advanced over ramp 266 and/or raised portion 264, prongs 262 and 263are flexed inwards. Preferably, the entrance to blind hole 272 has aninternal chamfer 288 so that ramp 266 is smoothly engaged as releasebutton 242 is advanced.

[0172] Release button 242 preferably has a generally cylindrical body285 which is slidably received within mating bore 294 (see FIG. 25) ofmount body 222. Release button 242 is retained in place, and its slidingtravel limited, by release button flange 241 on one end and spring clipor e-clip 293 assembled within e-clip groove 286 on the other end.Spring material 246, such as a wave spring washer or foam material, maybe disposed between release button flange 241 and mount body 222 to biasrelease button 242 outwards. Transverse to blind hole 272 tip portion289 also has a clearance slot 287 through which base post 230 passes.

[0173] For clarity only, FIGS. 22A-25 have illustrated instrument mountassembly 220 without hinge member 115 and cam 145 attached. However,hinge member 115 having rail grip 116 is preferably pivotally mounted,with cam 145 in place, by way of pins or the like at hinge mount 228 asdescribed above with reference to instrument mount assembly 20. Asdiscussed above, cam 145 may be rotated about cam guide 223 using baselever 122 to secure the instrument mount to a rail or other suitablestructure.

[0174] The retractor and instrument mounts described above can be usedto mount and stabilize a great number of instruments for use duringsurgery. Preferably, the retractor and instrument mounts are used tomount a mechanical stabilizer for stabilizing at least a portion of thebeating heart during CABG surgery or the like. Described below are anumber of mechanical stabilizer embodiments that are particularlybeneficial for stabilizing the beating heart, especially when used inconjunction with the retractors and instrument mounts described above.

[0175] Tissue Stabilizers

[0176] Once access to the heart is achieved, and the heart is positionedif necessary, a means for stabilizing the beating heart is introducedthrough the opening created and at least one component of thestabilizing device of the present invention is brought into contact withthe beating heart. The surgeon then applies a stabilizing force to thebeating heart via the stabilizing means which may then be fixed in placeby attachment to a fixed support. When a retractor or platform is fixedin an open position to expose the heart, the retractor platform may alsoprovide the stable support structure to which the stabilizing means isaffixed. When the position of the stabilizing means is fixed byattachment to a stable support or to the retractor platform, thestabilizing force is maintained for the duration of the procedure.

[0177] The structure of the portion of-the stabilizing means whichcontacts the heart may include one or more contact members which exert astabilizing force on the heart proximate to the site of the anastomosis.A pair of contact members may be plates or rectangular members which areplaced on either side of the target coronary artery at the site of theanastomosis and which may have friction means or tissue spreading orcompressing apparatus associated therewith. The contact members may alsobe provided by a platform which may be substantially planar or which maybe contoured to fit conformingly on the surface of the heart. Thestabilizing means may also include a shaft means having severalalternative embodiments to facilitate adjusting the position andorientation of the instrument. For example, the shaft means may have anadjustable length and the axis of the shaft means may have at least oneball joint disposed within its length such that the orientation of theshaft means relative to another structure such as the contact members orstable support may be continuously varied. As is apparent from thedescription of the several embodiments, each of the individualembodiments described and illustrated herein has discrete components andfeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments.

[0178] Referring to FIGS. 33-37, a preferred stabilizer assembly forstabilizing the beating heart is comprised of a foot or base portion 553attached to a rigid or semi-rigid shaft means or connecting shaft 3.Base portion 553 typically has one or more contact members 1 adapted tocontact the heart adjacent the site desired to be stabilized. Thecontact members 1 may be substantially planar, may be slightly curved toconform to the shape of the heart, or may be a non-conforming curve toestablish contact between only a portion of the contact member 1 and thebeating heart. The shape of the contact members may be varied dependingon the clinical assessment by the surgeon, the design of the otherfeatures of the stabilizing means, or the design of other instrumentsused to complete the anastomosis. In some embodiments the contactmembers 1 may have apertures, openings or attachments to facilitateconnection with sutures or other devices to achieve the requisitestabilization, occlusion of the target vessel, or exposure of the targetvessel. Examples of suitable base portions and contact members can befound, for example, in co-pending U.S. patent application Ser. No.08/931,158 filed on Sep. 16, 1997, entitled “SURGICAL INSTRUMENTS ANDPROCEDURES FOR STABILIZING THE BEATING HEART DURING CORONARY ARTERYBYPASS GRAFT SURGERY”, the entirety of which is herein incorporated byreference.

[0179] Referring to FIGS. 33 and 34, the proximal end of connectingshaft 3 has handle mechanism 468 assembled thereto which, among otherthings, provided the user with a means for locking an end effectoroperably attached to the distal end of connecting shaft 3. The mechanism468 is rotatably secured to the proximal end of the shaft means 3 and isformed at a selected angle to the shaft means to permit a surgeon toswivel the mechanism to a preferred position where the knob 504 is morereadily accessible to allow quickly locking the shaft means 3 in theorientation selected. In addition, the angled axis of the knob 504relative to the shaft means 3 reduces the tendency of the shaft means 3to rotate about its axis when a surgeon applies torque to the knob 504to lock the associated locking mechanism. The knob 504 is secured to ascrew 539 by suitable means such as press fitting, bonding, etc. Rightand left handle covers 540,541 comprise the handle 503 and provide thesupport for the handle mechanism. When assembled, the covers definegenerally a cylinder formed with a selected curvature. A secondary innermolding, generally indicated at 542, includes various integrally formedannular walls and shoulders for supporting and containing the knob 504and screw 539, as well as a cooperating nut 543, and arcuate wedge 544,a shaft retaining ring 545, the proximal end of the shaft means 3, and aproximal end of the translatable pushrod 505. The proximal end of theshaft means 3 includes an annular retaining ring slot 546 which securesthe proximal end of the shaft means 3 within suitable annular walls inthe corresponding end of the handle covers 540, 541 when the retainingring 545, confined by shoulders in the inner molding 542, is snappedinto the slot 546 and the covers are assembled. The nut 543 is confinedby shoulders in the inner molding 542, and the arcuate wedge 544 isslidably confined by correspondingly arcuate walls 547 also formed inthe inner molding.

[0180] As may be seen, rotation of the threaded screw 539 within theconfined threaded nut 543, causes translation of the screw, pivoting andthus translation of the translatable wedge 544 which abuts the screw,and translation of the pushrod 505 which abuts the translatable wedge.As is further described relative to FIGS. 35-37, any tightening orloosening of the screw 539, however slight, will cause a correspondingtranslation of the pushrod 505 into or out of the shaft means 3.

[0181] As depicted in the Figures, the shaft means 3 and thus thepushrod 505, are formed with a slight arcuate configuration, whichpermits additional degrees of freedom and movement and orientation ofthe distal end of the shaft means 3 and thus of the heart contact member1. Rotation of the shaft means 3 about the axis of confinement withinthe shaft grip 495 or 495 a, moves the distal end of the shaft means 3through a circular path while changing the angles through which thecontact member 1 can be oriented. This allows a surgeon to convenientlyachieve a wider range of positions and orientations of the contactmember relative to the patient's heart, while keeping the proximal endof the shaft means 3 and handle mechanism 468 out of the way as much aspossible.

[0182] FIGS. 35-37 illustrate an associated mechanism for maneuverablysupporting the various embodiments of the contact member 1 and forcooperatively assisting in the quick locking of the contact member by apartial rotation of the knob 504 once the member is positioned. To thisend, the distal end of the shaft means 3 is provided with exteriorthreads matching interior threads in a ball/socket 548. The distal endof ball/socket 548 is provided with slots 549, whereby the remainingmaterial comprises short extended tips 550 which, when bent in orinwardly formed, form a socket. A ball/post 551 includes a ball at oneend and a post at the other. When the mechanism is assembled, theball/post 551 is inserted into place within the ball/socket 548 with theball in the socket and the post protruding from the ball socket. Amechanism for providing a preloaded source, such as a compression spring552, is coupled to the ball/socket 548 abutting the ball. The spring 552is urged by the distal end of the shaft means 3 to exert a preloaded orconstant minimum force against the ball of the ball/post 551. The postof the ball/post 551 is solidly fixed as by pressing fitting, welding,etc., to the contact member 1. The distal end of the pushrod 505 passesthrough the spring 552 to abut the ball of the ball/post 551. Thus whenthe screw 539 is not tightened, the distal end of the pushrod 505 exertsa slight pressure against the ball, however the spring 552 maintains apreloaded force against the ball sufficient to maintain the contactmember 1 at any orientation set by a surgeon. When the screw 539 istightened, the pushrod 505 is forced against the ball to prevent anyfurther movement of the contact member 1. As may be seen, the contactmember 1 can be tilted to assume many orientations since the narrowcenter of the post can tilt into any of the four slots in theball/socket 548. In addition, simultaneous rotation of the curved shaftmeans 3 provides a surgeon with an even greater variety of orientationsof the contact member relative to a patient's heart.

[0183] The contact member 1 includes a preferred configuration whichimproves the size of the area of the heart which is visible to a surgeonwhile still providing the required suppression of heart movementnecessary to enable the efficient construction of the anastomosis. Moreparticularly, the pair of spaced-apart contact members 1 extend from acommon base portion 553, which uniquely first extends back away from thetips of the contact members at the point of attachment to the post, asshown at reference number 554. The spaced contact members 1 then curvedownward away form the common base portion 553 and back past the postand away from the shaft means 3. As may be seen in the FIGS. 35-37, thecontact member 1 of this embodiment uniquely is attached to the post onthe same surface as the surface that bears against the surface of thebeating heart. Since the members 1 separate at the base portion 553 at apoint 555 behind the distal end of the shaft means 3, a surgeon has anunobstructed and thus optimum view of the heart even below the distalend of the shaft means 3.

[0184] The contact members preferably include friction means 556selectively secured to the bottom surfaces thereof to more securelyengage a beating heart. In addition, the tips of the contact members arebent upward in the form of “ski tips” to lessen their impact when thecontact members are firmly pressed against a beating heart to suppressthe anastomotic site.

[0185] Although screw means 539/504/543 is illustrated herein as alocking mechanism of the handle mechanism 468, it is to be understoodthat other mechanisms may be employed. For example, a cam/levermechanism may be attached to a rod which in turn imparts a pivotingmovement or translation to a suitable bellcrank or pivotable member,which in turn imparts translation to pushrod 505 of the shaft means 3.Thus, locking mechanisms other than those specifically described hereinmay be used.

[0186] The basic configuration as just described with reference to baseportion 553 provides the maneuverability necessary to access andstabilized any desired vessel on the surface of the beating heart.However, the exact manner and position in which the stabilizer may beplaced relative to the vessel and the surgical techniques preferred byan individual surgeon may vary significantly. Accordingly, there is somepotential that certain combinations of stabilizer positioning mayinterfere somewhat with the preferred surgical technique of a particularsurgeon. The embodiments illustrated below with respect to FIGS. 38-40Balleviate any such problems.

[0187] One useful variation, as illustrated in FIG. 38, connectsconnecting shaft 3 to the base portion of the stabilizer at a positionwhich is generally offset from the center or off-center. Base portion710 is again typically formed of a unitary piece of sheet material andhas a curved back portion in which connecting shaft 3 is attached to anextension of the same surface which carries the contacting members,except that the connecting point 718, to which ball/post 551 is attachedis positioned away from the center and therefore away from the spacebetween contact members 712 where the anastomosis would be performed.This configuration tends to ensure that connecting shaft 3 will notinterfere with the surgical access to the center area of the baseportion. Of course, the connection can be offset from the central regionin either direction.

[0188] In addition, base portion 710 illustrates a number of featuresfor improving the traction and vessel presentation during a CABGprocedure on a beating heart. Contact members 712 of base member 710have portions 713 having an increased width and which are preferablysubstantially flat or slightly curved to conform to the heart. Thisconfiguration provides a larger area for coined regions 715, whichrepresent indentations on the bottom surface for receiving a tractionmaterial, thus providing greater traction against the surface of theheart.

[0189] Further, base portion 710 provides a smaller open space betweencontact members 712. In a preferred embodiment, the spacing 716 betweencontact members 712 is less than about 0.350 inches, more preferablyless than about 0.300 inches, and most preferably about 0.25 inches.This minimized spacing provides stabilization closer to the vessel and,in some instances, the compressive forces applied through contactmembers 712 actually tend to present the vessel upwards between contactmembers 712 in a more favorably pronounced manner. The tip portions 714of contact members 712 are angled upwards from the surface of the heartto minimize any possible trauma to the heart during use.

[0190] As just discussed, the base portions (550 or 710) can bemanipulated or oriented relative to the end of the connecting shaft 3 byvirtue of the ball and socket joint between base portion 553 andconnecting shaft 3. The amount of angular manipulation or travelavailable is somewhat limited as ball/post 551 eventually bottoms out orstops against either the bottom of slots 549 or extended tips 550. Thus,the contact members have a limited range of movement relative toconnecting shaft 3 based upon the nominal mounting relationship betweenthe contact members and the ball/post. Accordingly, for some procedures,it may be desirable to have a different nominal relationship between thecontact members and the ball/post to shaft connection.

[0191] Referring to FIGS. 39-40B, base member 720 illustrates analternative orientation of ball/post 551. Instead of being angled awayfrom the contact members, base member 720 has a back portion 721 whichallows ball/socket 551 to be mounted generally parallel to contactmembers 722. Ball/post 551 preferably extend towards contact members 722as shown, but may also extend the opposite direction away from thecontact members. The connecting point 723 is preferably offset adistance 724 from the central area between the contact members 722. Theconnecting point 723 is also off set a greater distance 726 from thecontacting place of contact members 722. In nominal position of baseportion 722 relative to ball/post 551, this configuration tends to keepthe connecting shaft 3 clear from the central portion between contactmembers 722. Furthermore, relative to connecting shaft 3, contactmembers 722 can be maneuvered through a range of motion different frombase member 553 due to the initial orientation of ball/post 551.

[0192] Because the preferred location of the attachment of theconnecting shaft 3 to the base portion may be different from surgeon tosurgeon and from procedure to procedure, it may be desirable to have theball/post moveable to more than one location. In one embodiment shown inFIG. 41, for example, ball/post 562 has threaded end 561 which may bethreaded into any desired threaded receiving hole 563 provided instabilizer base 560. Ball post 564 is preferably provided with one ormore flats 564 on the exterior thereof to facilitate tightening orloosening of the threaded connection. In the embodiment shown,stabilizer base 560 has threaded receiving holes 563 to provide center,offset right, and offset left connecting positions.

[0193] Referring to FIGS. 42 and 43, ball/post 572 may be capturedwithin slot 571 formed in stabilizer base 570. Slot 571 preferably hastwo or more positions where the ball/post can be positively locked. In apreferred embodiment, slot 571 preferably has two or more key-holeopenings 573. Key openings 573 are sized to receive first post portion577 having an outside diameter which closely matches the insidedimension of key opening 573. First post portion 577 of ball/post 572 isreleased from key hole 573 by pulling ball post in the directionindicated by arrow 579 until second post portion 578 is positionedwithin keyhole 573. Second post portion 578 is sized to have an outsidediameter small enough to fit and traverse through slot 571. Ball/post572 may then be traversed along the path defined by slot 571 until thenext desired key hole is reached, which may then be engaged by firstpost portion 577 to secure ball/post 572 in position on stabilizer base570.

[0194] First post portion 577 may be kept in engagement with keyholes573 by any convenient manner. For example, ball/post 572 may be springbiased in the locked position between upper flange 574 and lower flange575, preferably using spring washers 576 as shown. Ball/post 572 mayalso be locked into operating position within keyholes 573 by using aretaining or locking clip, such as locking clip 580 illustrated withreference to FIGS. 44 and 45. Locking clip 580 has slot 584 adapted toslide over second post portion 578. Locking clip 580 includes a thinportion 585, a thick portion 583, a transition ramp 582 between thinportion 585 and thick portion 583, and a grip or handle portion 581.With locking clip 580 in the open position shown in FIG. 44, ball post572 is free to move upwards in the direction of arrow 579, thusreleasing first post portion 577 from key hole 573. When locking clip580 is moved in the direction indicated by arrow 586, the outerthickness of thick portion 583 is wedged between lower flange 575 andstabilizer base 570, thus locking ball/post 572 in place within keyhole573.

[0195] Stabilizer base 590 in FIG. 46 has ball/post 592 mounted to anarticulating member which is moveable between two or more positions.Preferably, ball/post 592 is mounted on first end 594 of pivoting link591 which is pivotably attached to stabilizer base 590 at pivot pin 596.Preferably, pivot pin 596 is centrally located on pivoting link 591. Atsecond end 593 of pivoting link 591, a locking knob 595 may be providedto engage stabilizer base 590. Preferably, locking knob 595 has athreaded shaft or other such fastening or locking feature which engagesmating threaded holes (typically one positioned under locking knob 595and one under ball/post 592) in stabilizer base 590. The ball/post 592and locking knob 595 are preferably spaced equal distances from pivotpin 596 such that when pivoting link 591 is rotated as indicated byarrow 597, the position of ball/post 592 and locking knob 595 arereversed.

[0196] Another embodiment of a tissue stabilizer having an adjustableattachment position of the connecting shaft is illustrated in FIGS.47-50. Stabilizer base assembly 625 includes top member 605 andstabilizer base 600, having contact members 606 and 607 and notch orrelief 603 under which a vessel may safely pass without being occluded.At least a portion of stabilizer base 600 has outer profile 601 which isgenerally curved or circular at a predetermined radius. Top member 605has a mating interior curvature such that stabilizer base 600 and topmember 605 concentrically rotate relative to each other, preferablyabout a common center point. Ball/post 602 may be attached at aconvenient position, typically centered, on top member 605. Rotation oftop member 605 relative to stabilizer base 600, as indicated by arrows620 and 619, thus adjusts the position of ball/post 602 along an arcuatepath relative to contact members 606 and 607.

[0197] To facilitate the secure attachment and smooth rotation of topmember 605 relative to stabilizer base 600, top member 605 may beprovided with one or more projections adapted to be received withinguide slots provided in stabilizer base 600. In a preferred embodiment,top member 605 has side projections or rails 608 and 609 which snap intolower slots or channels 611 and 610 in stabilizer base 600 as top member605 is urged into a concentric position over stabilizer base 600. Rails608 and 609 slide within channel 611 and 610 to maintain a secureattachment and controlled rotation of top member 605 and stabilizer base600. Top member 605 may optionally have tab 612 adapted to be receivedwithin upper slot 604 on stabilizer base 600. Upper slot 604 may have aplurality of detents or teeth which form a desired number of detentedpositions as tab 612 is rotated around the path of upper slot 604. In apreferred embodiment, detented position 617 is formed between tooth 613and slot end 616 and detented position 618 is formed between tooth 614and tooth 615. Of course, detented positions may be created at anydesired location using a variety of alternate constructions. Preferably,the detent action of tab 612 allows the operator to manually select aposition of ball/post 602, but then holds the position of top member 605relative to stabilizer base 600 against movement during use to ensureeffective stabilization of a target vessel on the beating heart.

[0198] In addition to the critical function of stabilizing the beatingheart, it is also important for the tissue stabilizer to present thestabilized coronary artery in a manner which allows sutures to be easilyplaced around the mouth of the arteriotomy as required to create theanastomosis. FIGS. 51A-54 illustrate a tissue stabilizer embodimentinvolving a base portion having a single contacting surface forstabilizing a target vessel on the beating heart and a mechanical bailelement to facilitate optimal vessel presentation.

[0199] Referring to FIGS. 51A and 51B stabilizer base 740 is shownattached to connecting shaft 3 using ball/post 730. Connecting shaft 3is shown connected generally to the center of stabilizer base 740 atapproximately a right angle, however, as discussed above, the ball/post730 could be connected at any desired offset or orientation or theposition of ball/post 730 could be adjustable. Stabilizer base 740preferably has a single contacting surface 742 which may be flat orcurved to at least partially conform to the surface of the heart.Contacting surface 742 is sized to provide sufficient contacting areasuch that sufficient compressive force can be applied to the beatingheart to achieve effective immobilization or stabilization of a targetcoronary artery.

[0200] Stablizer base 740 preferably has an extending frame member orbail 745 attached thereto. Bail 745 may be a thin, round or squarecross-sectioned member, and is preferably a stainless steel wire. Bail740 has a bail portion 756 which is generally parallel to stabilizerbase 740 and may have relieved sections 747 formed therein so as not toocclude the vessel during use. Bail portion 756 may have tissue grippingfeatures, such as teeth 755. In an optional embodiment, bail portion 756may be provided with rotating cover or a spiral wound thread (not shown)so that bail portion may be more easily repositioned, under astabilizing load, over the surface of the heart as discussed below.

[0201] In a preferred embodiment, bail 745 is moveable relative tostabilizer base 740.

[0202] Bail 745 can be moved in or out in the direction indicated byarrow 750 to cause bail section 756, which is generally parallel withstabilizer base 740, to compress tissue towards stabilizer base 740 orstretch tissue away from stabilizer base 740. Thus, bail 745 can bemoved in and out to compress or stretch the tissue surrounding acoronary artery until the optimum presentation for performing theanastomosis is achieved. The generally parallel portion may bevertically offset from contacting surface 742 by a distance 757 which istypically about 0.050 inches to about 0.200 inches.

[0203] Although bail 745 may be attached in a number of ways, bail 745is preferably formed with first and second end portions 748 and 749having detents or teeth 746. Stabilizer base 740 preferably has channels751 and 752 for receiving end portions 749 and 748 respectively.Channels 751 and 752 preferably have internal mating teeth 753 forengaging teeth 746. End portions 748 and 749 can be incrementallyadvanced into channels 752 and 751 as teeth 746 deflect and release froma mated position relative to teeth 753 and then successively engage thenext mated position. Stabilizer base 740 may include cover 754 overchannels 751 and 752. So that the stabilizer can be removed from arounda completed anastomosis, at least one end of bail 745 is detachable fromstabilizer base 740. In a preferred embodiment, stabilizer base 740 issubstantially symmetrical allowing bail 745 to be assembled from eitherside in a right or left handed configuration.

[0204] Bail 745 is preferably flexible or semi-flexible relative tostabilizer base 740. As a result of its inherent flexibility, bail 745applies a predetermined force against the heart that, under operatingconditions, may be generally independent of the stabilizing forceapplied to stabilizer base 740 to stabilize the beating heart. That is,once stabilizer base 740 is forced against the surface of the heart, theforce applied by bail 745 is a function of its mechanical spring raterelative to stabilizer base 740.

[0205]FIGS. 52A and 52B illustrate another single contact stabilizerbase having a bail 762 which is secured at only one end. Stabilizer base760 may have a housing 765 having a series of internal teeth (notshown). Bail 762 has a toothed end 766 which is received within housing765 to engage with the mating teeth provided therein. As with theembodiment above, bail 762 has a generally parallel portion 763 which ismoveable relative to stabilizer base 760 in the direction generallyindicated by arrow 767 to stretch or compress the surrounding tissue foroptimum vessel presentation. Bail 762 may have tab 761 to facilitategrasping by an instrument, such as for example forceps 761. The free end764 of bail 762 is preferably rounded or somewhat bulbous so as to beatraumatic. Because bail 762 attaches only at one end, the stabilizercan be easily removed from the completed anastomosis without removingbail 762 from stabilizer base 760.

[0206] In another embodiment of the stabilizer, the wire frame member orbail may have a drive mechanism for moving the bail relative to thestabilizer base. Referring to FIG. 53 stabilizer base 770 has housing771 which is constructed with guide channel 774 having gear 775 mountedfor rotation therein. Bail 772 has a toothed end 773 which may beassembled within guide channel 774 such that rotation of gear 775 causesbail 772 to be moved in and out in the direction indicated by arrow 43.Gear 775 may be driven by any suitable tool, for example, gear 775 mayhave a drive hole 778 for engagement by a suitable drive tool 771.

[0207] Another driven bail stabilizer is shown in FIG. 54. In thisembodiment, stabilizer base 780 has threaded shaft 781 preferablysupported at its end portions by bushings or bearings 783 and 784. Oneend of the threaded shaft is connected to a flexible drive 785 through aflexible or universal joint 791. The flexible drive may be routed upconnecting shaft 3. Preferably flexible drive 785 is secured toconnecting shaft 3 by way of a thin polymeric coating. Bail 782 isconnected to threaded collar 787 which cooperates with threaded shaft781 to move bail in and out relative to stabilizer base 780 in thegeneral direction indicated by arrow 790. The screw and collar drivemechanism is preferably concealed by housing 788 which has only a smallslotted opening 786 allowing passage of bail 782.

[0208] With each of the flexible bail embodiments described above,stabilization and vessel presentation are relatively independent. First,the beating heart is typically stabilized using a compressive forcedelivered by way of the single contacting surface provided by thestabilizer base. The bail may then be manipulated in or out to obtainthe optimum presentation of the vessel for whatever surgical procedureis underway. For example, one bail position may be optimal for creatingthe arteriotomy, another bail position for insertion of a shunt or likedevice (should one be used), another bail position for creating theanastomosis, and so on. All the while, the stabilization of the beatingheart itself remains optimized by the contacting surface of thestabilizer base.

[0209] The Stabilization System

[0210] Preferred embodiments for each of the retractor, the instrumentmount and the tissue stabilizers have been discussed in detail above.While each component may be utilized separately, superior access andstabilization can be achieved when the multiple components are usedtogether for performing a minimally invasive cardiac surgery, preferablythrough a sternotomy approach. Referring to FIG. 55, retractor assembly900, including drive mechanism 910 and first and second platform blades915 and 920, may be used to spread the sternum, providing access anddirect visualization to the thoracic cavity. Retractor assembly 900 alsoallows sutures to be fixed or organized. Stabilizer assembly 800isolates and provides local immobilization of the target vessel on thebeating heart. Instrument mount assembly 850 facilitates precisemaneuvering of the stabilizer and ensures a stable, motion free mount atthe desired position and orientation.

[0211] To begin a typical beating heart CABG procedure using thepreferred stabilization system illustrated in FIG. 55, drive mechanism910 is preferably placed in the fully closed position with moveablehousing 925 positioned against or adjacent fixed housing 930. Firstplatform blade 915 is then assembled to moveable housing 925 and asecond platform blade 920 is assembled to fixed housing 930. Afterensuring that platform blades 915 and 920 are fully and securelyattached to drive mechanism 910, engaging members 935 of platform blades915 and 920 are securely seated on the incised sternum created usingstandard surgical procedures. Drive handle 940 may then be rotatedclockwise to separate platform blades 915 and 920, thus creating thedesired opening for accessing the beating heart.

[0212] If positioning the heart using sutures to position the heart, thesutures may be placed through the tissue at the desired location andsecured to platform blades 915 and 920. Sutures 945 may be slid intosuture holder slots 950 to engage the suture. To ensure proper a properhold, only one suture strand is preferably engaged within each sutureholder slot 950. Sutures 945 are released from platform blades 915 and920 by concurrently pulling back and up on suture 945 while pulling thesuture through the suture holder slot 950.

[0213] With the heart positioned as desired, instrument mount assembly850 may be assembled to platform blade 920 (or 915) by hookingstabilizer mount base 955 onto rail 960 (or 961) at the desired locationand moving the base lever (not visible in this view) clockwise to theclosed position to secure instrument mount assembly 850 onto rail 960.Mount body 110 may be oriented to the desired angle by way of ball joint965 and locked into place by turning the top mount knob 855 clockwise.

[0214] Stabilizer base 810, having contact members 812 and 814, may thenbe positioned on the epicardium of the beating heart by gently loweringconnecting shaft 820 using one hand to guide stabilizer base 810 ontothe target area on the heart. Incremental pressure is applied tostabilizer base 810 situated on the epicardium until the desiredimmobilization or stabilization is achieved. Connecting shaft 820 issecured in the desired position by turning side mount knob 860 clockwiseand stabilizer base 810 is secured in the desired position relative toconnecting shaft 820 by turning the stabilizer shaft knob 830 clockwise.With the beating heart stabilized the anastomosis, or other desiredprocedure, is completed.

[0215] To remove stabilizer base 810, connecting shaft 820 is held withone hand while side mount knob 860 is loosened with the other hand.Stabilizer base 810 is then carefully removed from the anastomotic site.The base lever is moved to the open position to release instrument mountassembly 850, and stabilizer assembly 800 mounted thereto, from rail 960on platform blade 920. When the entire bypass procedure is completed,drive handle 940 is rotated in the counter clockwise direction to closedrive mechanism 910 and platform blades 915 and 920. Retractor assembly900 may then be gently removed from the access incision. To removeplatform blades 915 and 920 from moveable housing 925 and fixed housing930, respectively, release latches 970 are manually activated andplatform blades 915 and 920 may be pulled generally straight away fromdrive mechanism 910. Drive mechanism 910 may then be sterilized andprepared for use in a subsequent procedure.

[0216] While certain embodiments are illustrated in the drawings andhave just been described herein, it will be apparent to those skilled inthe art that many modifications can be made to the embodiments withoutdeparting from the inventive concepts described. For purposes ofillustration only, the principles of the present invention has beengenerally described with reference to a coronary artery bypassprocedure, but may readily be applied to other types surgical proceduresnot specifically described. Many other uses are well-known in the art,and the concepts described herein are equally applicable to those otheruses. Further, the different components of the various exemplarembodiments described above can be combined in any desirableconstruction. Accordingly, the invention is not to be restricted exceptby the claims which follow.

What is claimed is:
 1. An apparatus for stabilizing a localized portionof a beating heart, comprising: a substantially rigid base member havingat least one contact area adapted to frictionally engage the surface ofthe beating heart adjacent a first side of a target vessel; and a wireframe coupled to said base member, said wire frame having a frameportion adapted to engage the beating heart adjacent a second side ofsaid target vessel opposite to said first side and at least one legportion, said leg portion connecting said frame portion to said basemember.
 2. The apparatus of claim 1 further comprising a shaft having aproximal end and a distal end, said base member being operably connectedto said distal end.
 3. The apparatus of claim 2 wherein said shaft issubstantially rigid.
 4. The apparatus of claim 3 wherein said shaft iscurved.
 5. The apparatus of claim 1 wherein said leg portion issubstantially perpendicular to said frame portion.
 6. The apparatus ofclaim 1 wherein said wire frame is moveable relative to said basemember.
 7. The apparatus of claim 6 wherein said base member furthercomprises a channel for slidably receiving at least a portion of saidleg portion.
 8. The apparatus of claim 7 wherein said leg portion has aplurality of detented positions within said channel.
 9. The apparatus ofclaim 8 wherein said channel further comprises a plurality of teeth andsaid leg portion further comprises a plurality of mating teeth adaptedto engage said teeth.
 10. The apparatus of claim 1 wherein said legportion is substantially flexible relative to said base member.
 11. Theapparatus of claim 10 wherein said wire frame is formed from a unitarylength of wire material.
 12. The apparatus of claim 11 wherein the wirematerial is selected from the group consisting of stainless steel andtitanium.
 13. The apparatus of claim 1 wherein said frame portion has afirst end and a second end and said wire frame comprises a first legportion attached to said first end and a second leg portion attached tosaid second end, said first and second leg portions being coupled tosaid base member.
 14. The apparatus of claim 13 wherein said baseportion further comprises a first channel and a second channel forslidably receiving said first leg portion and said second leg portionrespectively.
 15. The apparatus of claim 6 wherein said base memberfurther comprises a pinion gear having a plurality of gear teeth andsaid leg portion further comprising a rack having a plurality of matingteeth adapted to engage said gear teeth.
 16. The apparatus of claim 6wherein said base member further comprises a threaded shaft rotatablycoupled to said base member, and said leg portion further comprises acollar having a threaded interior adapted to receive said threadedshaft.
 17. The apparatus of claim 1 wherein said frame portion isvertically offset from said at least one contact area.
 18. The apparatusof claim 17 wherein said vertical offset is between about 0.05 inches toabout 0.2 inches.
 19. The apparatus of claim 17 wherein said at leastone contact area is substantially planar.
 20. The apparatus of claim 1wherein said at least one leg portion further comprises a verticallyrelieved portion.
 21. An apparatus for stabilizing a localized portionof a beating heart comprising: a substantially rigid base member formedfrom a unitary piece of sheet material having a first side and a secondside, said base member having a first section adapted to contact thesurface of the beating heart and a second section at a fixed angle tosaid first section, said first section defining a first contact surface,a second contact surface, and an open space therebetween; and aball-shaped member connected to said second section at a location whichis offset from said open space.
 22. The apparatus of claim 21 furthercomprising a post having a first end and a second end, said first endattached to said second section at said location and said second endattached to said ball-shaped member.
 23. The apparatus of claim 21further including a shaft having a proximal end and a distal end havinga socket operably engaged with said ball-shaped member.
 24. Theapparatus of claim 23 wherein said shaft is curved.
 25. The apparatus ofclaim 23 wherein said shaft is substantially straight.
 26. The apparatusof claim 21 wherein said angle is from about 75 degrees to about 105degrees.
 27. The apparatus of claim 26 wherein said angle is about 90degrees.
 28. The apparatus of claim 27 wherein said post extends fromsaid first side.
 29. The apparatus of claim 21 wherein said angle ismore than about 120 degrees and said post extends from said second side.30. An apparatus for stabilizing a localized portion of a beating heart,comprising: a substantially rigid base member having at least onesurface adapted to contact the surface of the heart, a post having afirst end moveably coupled to said base member and a second end having aball-shaped member extending therefrom.
 31. The apparatus of claim 30further comprising a shaft having a proximal end and a distal end, saiddistal end having a socket operably engaged with said ball-shapedmember.
 32. The apparatus of claim 30 wherein said shaft issubstantially rigid.
 33. The apparatus of claim 30 wherein said basemember has a first section having at least one surface for contactingthe surface of a heart and a second section adjacent said first section,said post being moveably coupled to said second section.
 34. Theapparatus of claim 33 wherein said second section is at an anglerelative to said first section.
 35. The apparatus of claim 33 whereinsaid second section has a slot adapted to receive said first end of saidpost, said first end being moveably within said slot from a firstposition to a second position.
 36. The apparatus of claim 30 wherein atleast a portion of said base member has a curved outer profile and saidpost is mounted to a top member having an interior profile adapted toengage and concentrically rotate about said curved outer profile. 37.The apparatus of claim 36 wherein said base member has at least oneelongate slot and said top member has at least one tab engaged withinsaid at least one slot.
 38. An apparatus for stabilizing a localizedportion of a beating heart, comprising: a base member having at leastone surface adapted to contact the surface of the heart, a link memberpivotably coupled to said base member at a predetermined pivot point,said link member having a first link end spaced a distance away fromsaid pivot point; and a post having a first post end attached to saidfirst link end and a second post end having at least a ball shapedmember extending therefrom.
 39. The apparatus of claim 38 furthercomprising a shaft having a proximal end and a distal end, said distalend having a socket operably engaged with said ball-shaped member. 40.The apparatus of claim 39 wherein said shaft is substantially rigid. 41.The apparatus of claim 38 wherein said link member has a second link endopposite said first link end, said second link end being releasablylocked to said base member to substantially prevent relative movement ofsaid link member relative to said base member.
 42. The apparatus ofclaim 38 wherein said link member pivots about a pivot pin extendingfrom said base member.
 43. The apparatus of claim 42 wherein said basemember has a first contact surface, a second contact surface, and anopen space therebetween.
 44. The apparatus of claim 43 wherein said linkmember has a first position wherein said post is offset from said openspace in a first direction and a second position wherein said post isoffset from said open space in a second direction.